PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Report

• Report Number: 1020279-2025-01696
• Event Type: Injury
• Date Received: October 15, 2025
• Report Date: October 28, 2025
• Manufacturer: SMITH & NEPHEW, INC.
• Product Code: JWH
• Adverse Event: Yes
• Report Source: Manufacturer report
• Reporter Location: SZ
• Reporter Occupation: OTHER
• Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE SWISS NATIONAL JOINT REGISTRY (SIRIS), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN SWITZERLAND FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY TKA JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - JOURNEY II BCS FEMORAL COMPONENT: A TOTAL OF TWO THOUSAND TWO HUNDRED AND FORTY-SIX (2,246) KNEES UNDERWENT PRIMARY TKA PROCEDURES BETWEEN 01-JAN-2012 AND 31-MAR-2025. FROM THESE, TWO HUNDRED AND THIRTY-EIGHT (238) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWO (2) KNEES DUE TO LOOSENING OF THE FEMORAL COMPONENT, TWENTY-TWO (22) KNEES DUE TO LOOSENING OF THE TIBIAL COMPONENT, NINETEEN (19) KNEES DUE TO LOOSENING OF THE PATELLAR COMPONENT, TWENTY-EIGHT (28) KNEES DUE TO INFECTION, FORTY-EIGHT (48) KNEES DUE TO FEMOROTIBIAL INSTABILITY, FIVE (5) KNEES DUE TO PATELLA INSTABILITY, ONE HUNDRED NINE (109) KNEES DUE TO PATELLA PROBLEMS, NINE (9) KNEES DUE TO FEMORAL COMPONENT MALPOSITION, THIRTEEN (13) KNEES DUE TO TIBIAL COMPONENT MALPOSITION, FOUR (4) KNEES DUE TO WRONG SIZE FEMORAL COMPONENT, ONE (1) KNEE DUE TO WRONG SIZE TIBIAL COMPONENT, ELEVEN (11) KNEES DUE TO JOINT STIFFNESS / ARTHROFIBROSIS, TWO (2) KNEES DUE TO WEAR OF INLAY, TWO (2) KNEES DUE TO FEMORAL PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO TIBIAL PERIPROSTHETIC FRACTURE, FOUR (4) KNEES DUE TO PATELLA PERIPROSTHETIC FRACTURE, SIXTEEN (16) KNEES DUE TO PAIN OF UNCLEAR ORIGIN, TWO (2) KNEES DUE TO PROGRESSION OF OSTEOARTHRITIS AND SEVENTEEN (17) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 238 REVISIONS HAS BEEN REPORTED IN SIRIS FOR THE JOURNEY II BCS FEMORAL COMPONENT. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE JOURNEY II BCS KNEE SYSTEM PRESENTS A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THIS SYSTEM IS AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. THE REVISIONS PER 100 COMPONENT YEARS FOR THE JOURNEY II BCS FOR CURRENT ON-LABEL USE WITH PATELLA RESURFACING HAS STRONGLY IMPROVED IN SWITZERLAND. JOURNEY II BCS COCR WITH PATELLA SHOWS A VALUE OF 0.80 WHICH IS FULL IN LINE WITH THE TKA CLASS (0.87). ONE HUNDRED (100) IMPLANTATIONS OCCURRED, WITH A SINGLE REVISION REPORTED IN THE FIRST YEAR AFTER IMPLANTATION. FOR JOURNEY II BCS OXINIUM THE REVISIONS PER 100 COMPONENT YEARS VALUE REPORTED IS 1.37, WHICH REPRESENTS A SUBSTANTIAL IMPROVEMENT FROM THE 2.02 VALUE CAPTURED IN THE 2022 REPORT. SIMILARLY, THE CUMULATIVE REVISION RATES HAVE LOWERED, ALTHOUGH REMAINING ABOVE THE CLASS. WHILE JOURNEY II BCS OXINIUM WITH PATELLA RESURFACING OVERALL SURVIVORSHIP REMAINED BELOW THE CLASS MEAN VALUE, SURVIVORSHIP OVER THE PAST 3-YEARS WAS INSTEAD IN LINE WITH THE CLASS. CONFOUNDING FACTORS RELATED TO OLDER IMPLANTATIONS SUCH AS IMPROVEMENT IN QUALITY OF TRAINING AND SURGICAL INSTRUCTIONS OVER THE YEARS, MAY CONTRIBUTE TO THIS DIFFERENCE. BASED ON CURRENT PERFORMANCE, THE SUBJECT DEVICES ARE CONSIDERED TO BE STATE OF THE ART AS IN LINE WITH THE CLASS. SPECIFIC ANALYSIS IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Additional Manufacturer Narrative · 0

CORRECTED DATA: B5 (EVENT NARRATIVE), H2 (TOTAL NUMBER OF EVENTS IS NOW 260), UDI NUMBER FIELDS IN THE ATTACHED CSV FILE HAVE BEEN UPDATED FOR THE LINE ITEMS LABELED AS 'VERSION 1' IN COLUMN AE ('LATEST LINE-ITEM VERSION'), H11 (UPDATED MANUFACTURER NARRATIVE) ADDITIONAL INFORMATION: ADDITIONAL LINE ITEMS PERTAINING TO COMPLAINTS CASE-(B)(4) HAVE BEEN ADDED TO THE .CSV FILE ATTACHED TO THE 3500A FORM. EXCEPT FOR THE UPDATES PROVIDED IN THE SECTIONS 'CORRECTED DATA' AND 'ADDITIONAL INFORMATION' OUTLINED ABOVE, NO OTHER CORRECTIONS OR ADDITIONAL INFORMATION HAVE BEEN INCORPORATED TO THE .CSV FILE OR THE INITIAL 3500A FORM PREVIOUSLY SUBMITTED ON OCTOBER 13, 2025. REPORTING QUARTER: 2 (APRIL 1 - JUNE 30, 2025). SUMMARY OF ADVERSE EVENTS: BASED ON REAL WORLD DATA FROM THE SWISS NATIONAL JOINT REGISTRY (SIRIS), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN SWITZERLAND FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - JOURNEY II BI-CRUCIATE STABILIZED (BCS) FEMORAL COMPONENT: A TOTAL OF TWO THOUSAND TWO HUNDRED AND FORTY-SIX (2,246) KNEES UNDERWENT PRIMARY TKA PROCEDURES BETWEEN 01-JAN-2012 AND 31-MAR-2025. FROM THESE, TWO HUNDRED AND THIRTY-EIGHT (238) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWO (2) KNEES DUE TO LOOSENING OF THE FEMORAL COMPONENT, TWENTY-TWO (22) KNEES DUE TO LOOSENING OF THE TIBIAL COMPONENT, NINETEEN (19) KNEES DUE TO LOOSENING OF THE PATELLAR COMPONENT, TWENTY-EIGHT (28) KNEES DUE TO INFECTION, FORTY-EIGHT (48) KNEES DUE TO FEMOROTIBIAL INSTABILITY, FIVE (5) KNEES DUE TO PATELLA INSTABILITY, ONE HUNDRED NINE (109) KNEES DUE TO PATELLA PROBLEMS, NINE (9) KNEES DUE TO FEMORAL COMPONENT MALPOSITION, THIRTEEN (13) KNEES DUE TO TIBIAL COMPONENT MALPOSITION, FOUR (4) KNEES DUE TO WRONG SIZE FEMORAL COMPONENT, ONE (1) KNEE DUE TO WRONG SIZE TIBIAL COMPONENT, ELEVEN (11) KNEES DUE TO JOINT STIFFNESS / ARTHROFIBROSIS, TWO (2) KNEES DUE TO WEAR OF INLAY, TWO (2) KNEES DUE TO FEMORAL PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO TIBIAL PERIPROSTHETIC FRACTURE, FOUR (4) KNEES DUE TO PATELLA PERIPROSTHETIC FRACTURE, SIXTEEN (16) KNEES DUE TO PAIN OF UNCLEAR ORIGIN, TWO (2) KNEES DUE TO PROGRESSION OF OSTEOARTHRITIS AND SEVENTEEN (17) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS FOR REVISION MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - JOURNEY II CRUCIATE-RETAINING (CR) FEMORAL COMPONENT: IMPLANTED IN THREE HUNDRED EIGHTY-SIX (386) KNEES BETWEEN 01-JAN-2012 AND 31-MAR-2025. FROM THESE, TWENTY TWO (22) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE (1) KNEE DUE TO LOOSENING OF THE FEMORAL COMPONENT, ONE (1) KNEE DUE TO LOOSENING OF THE TIBIAL COMPONENT, ONE (1) KNEE DUE TO LOOSENING OF THE PATELLAR COMPONENT, ONE (1) KNEE DUE TO INFECTION, THREE (3) KNEES DUE TO FEMOROTIBIAL INSTABILITY, FIFTEEN (15) KNEES DUE TO PATELLA PROBLEMS, ONE (1) KNEE DUE TO FEMORAL COMPONENT MALPOSITION, ONE (1) KNEE DUE TO TIBIAL COMPONENT MALPOSITION, TWO (2) KNEES DUE TO JOINT STIFFNESS / ARTHROFIBROSIS, ONE (1) KNEE DUE TO PAIN OF UNCLEAR ORIGIN AND TWO (2) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS FOR REVISION MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 260 REVISIONS HAVE BEEN REPORTED IN SIRIS FOR THE JOURNEY II TOTAL KNEE SYSTEMS REFERENCED ABOVE. ANALYSIS CONDUCTED: BASED ON THE MOST RECENT SAFETY AND PERFORMANCE EVALUATION, THE JOURNEY II BCS KNEE SYSTEM AND THE JOURNEY II CR KNEE SYSTEM PRESENT A FAVORABLE BENEFIT/RISK ASSESSMENT WHEN USED UNDER THE CONDITIONS AND FOR THE PURPOSES INTENDED BY THE MANUFACTURER AND WITH RESPECT TO THE CONTRAINDICATIONS AND PRECAUTIONS FOR USE AND WARNINGS DESCRIBED IN THE INFORMATION MATERIAL SUPPLIED WITH THE DEVICES. THESE SYSTEMS ARE AT LEAST AS SAFE AND EFFECTIVE AS ALL ITS THERAPEUTIC ALTERNATIVES IN THE TARGETED INDICATION. THE INTENDED PURPOSE AND INFORMATION FOR SAFETY INCLUDED IN THE INFORMATION MATERIALS SUPPLIED BY THE MANUFACTURER ARE ADEQUATE AND SUITABLE FOR THE INTENDED USES AND USERS. THE REVISIONS PER 100 COMPONENT YEARS FOR THE JOURNEY II BCS FOR CURRENT ON-LABEL USE WITH PATELLA RESURFACING HAS STRONGLY IMPROVED IN SWITZERLAND. JOURNEY II BCS COCR WITH PATELLA SHOWS A VALUE OF 0.80 WHICH IS FULL IN LINE WITH THE TKA CLASS (0.87). ONE HUNDRED (100) IMPLANTATIONS OCCURRED, WITH A SINGLE REVISION REPORTED IN THE FIRST YEAR AFTER IMPLANTATION. FOR JOURNEY II BCS OXINIUM THE REVISIONS PER 100 COMPONENT YEARS VALUE REPORTED IS 1.37, WHICH REPRESENTS A SUBSTANTIAL IMPROVEMENT FROM THE 2.02 VALUE CAPTURED IN THE 2022 REPORT. SIMILARLY, THE CUMULATIVE REVISION RATES HAVE LOWERED, ALTHOUGH REMAINING ABOVE THE CLASS. WHILE JOURNEY II BCS OXINIUM WITH PATELLA RESURFACING OVERALL SURVIVORSHIP REMAINED BELOW THE CLASS MEAN VALUE, SURVIVORSHIP OVER THE PAST 3-YEARS WAS INSTEAD IN LINE WITH THE CLASS. CONFOUNDING FACTORS RELATED TO OLDER IMPLANTATIONS SUCH AS IMPROVEMENT IN QUALITY OF TRAINING AND SURGICAL INSTRUCTIONS OVER THE YEARS, MAY CONTRIBUTE TO THIS DIFFERENCE. BASED ON CURRENT PERFORMANCE, THE SUBJECT DEVICES ARE CONSIDERED TO BE STATE OF THE ART AS IN LINE WITH THE CLASS. FOR THE JOURNEY II CR SYSTEM, KAPLAN-MEIER ESTIMATES OF FIRST REVISION RATES OF ANY COMPONENT (OXINIUM OR COBALT-CHROMIUM) WERE IN LINE WITH THE TKA CLASS BASED ON OVERLAPPING CONFIDENCE INTERVALS. REVISION RATES PER 100 COMPONENT YEARS AT FIRST REVISION ARE AVAILABLE AND FURTHER STRATIFIED BY FEMORAL COMPONENT VARIANT AND BY PATELLA RESURFACING AT PRIMARY TKA. THERE IS NO STATISTICALLY SIGNIFICANT DIFFERENCE FROM THE RESPECTIVE TKA CLASS FOR WITH AND WITHOUT PATELLA RESURFACING AT PRIMARY TKA FOR BOTH JOURNEY II CR OXINIUM AND COCR FEMORAL COMPONENTS BASED ON NON-OVERLAPPING OF CONFIDENCE INTERVALS. SPECIFIC ANALYSIS IN SCOPE OF THIS MDR SUBMISSION IS PROVIDED IN THE ATTACHED .CSV FILE. BASED ON THE REVIEW OF OTHER CLINICAL SOURCES SUCH AS CLINICAL ACTIVITIES, COMPLAINT DATA, PUBLISHED LITERATURE AND OTHER JOINT REGISTRIES, NO INCREASED RISKS TO HEALTH OR AN INCREASED TREND IN ANY OF THE ADVERSE EVENTS SUMMARIZED ABOVE HAVE BEEN IDENTIFIED. THE REPORTED ADVERSE EVENTS RELATE TO KNOWN INHERENT PROCEDURAL RISKS THAT ARE APPROPRIATELY DOCUMENTED IN OUR RISK FILES. NO INDIVIDUAL INVESTIGATIONS INTO THE REPORTED ADVERSE EVENTS ARE DEEMED NECESSARY. ADDITIONAL ACTION(S) TAKEN: NO ADDITIONAL ACTIONS ARE DEEMED NECESSARY AT THIS TIME. SMITH+NEPHEW WILL CONTINUE TO MONITOR TRENDS IN ACCORDANCE WITH OUR POST-MARKET SURVEILLANCE PROCESS AND TAKE NECESSARY ACTION AS REQUIRED IF ANTICIPATED SEVERITY AND/OR OCCURRENCE RATES ARE EXCEEDED.

Description of Event or Problem · 0

Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2025-00280093-1-L1,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2013 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,61,Male,,1/1/2013,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L2,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2013 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,78,Female,,1/1/2013,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L3,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2014 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,46,Male,,1/1/2014,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L4,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patellar instability, femoral component malposition, tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Female,,1/1/2015,,E1615,F1905,A24;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L5,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Female,,1/1/2015,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L6,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2013 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,55,Female,,1/1/2013,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L7,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Female,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L8,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Female,,1/1/2015,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L9,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,78,Male,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L10,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,61,Male,,1/1/2015,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L11,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Male,,1/1/2015,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L12,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,51,Male,,1/1/2016,,E161604,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L13,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: wrong size of femoral component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Male,,1/1/2016,,E2401,F1905,A2303,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L14,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,81,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L15,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2014 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Female,,1/1/2014,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L16,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: femoral periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Female,,1/1/2016,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L17,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Male,,1/1/2015,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L18,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2013 due to: other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Male,,1/1/2013,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L19,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Female,,1/1/2016,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L20,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2013 due to: patella problems, pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,44,Female,,1/1/2013,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L21,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L22,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8,74022128,,74022128,,00885556170564,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patellar instability, patella problems, other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Male,,1/1/2016,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L23,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8,74022128,,74022128,,00885556170564,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Male,,1/1/2015,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L24,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8,74022128,,74022128,,00885556170564,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2014 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Male,,1/1/2014,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L25,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,51,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L26,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2013 due to: tibial periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,50,Female,,1/1/2013,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L27,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: loosening of tibial component, femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,50,Male,,1/1/2016,,E161201;E1615,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L28,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,83,Female,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L29,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems, joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,72,Male,,1/1/2016,,E161604,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L30,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,50,Male,,1/1/2016,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L31,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Male,,1/1/2016,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L32,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,57,Female,,1/1/2016,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L33,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Female,,1/1/2016,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L34,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: infection, other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Male,,1/1/2016,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L35,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: femoral component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,69,Male,,1/1/2016,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L36,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: loosening of tibial component, tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Female,,1/1/2015,,E161201;E2308,F1905,A0103;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L37,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,57,Male,,1/1/2016,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L38,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,49,Female,,1/1/2015,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L39,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,78,Female,,1/1/2016,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L40,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Male,,1/1/2016,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L41,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,52,Male,,1/1/2015,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L42,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Female,,1/1/2015,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L43,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,83,Female,,1/1/2017,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L44,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,65,Male,,1/1/2015,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L45,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L46,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Female,,1/1/2017,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L47,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,84,Female,,1/1/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L48,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,52,Female,,1/1/2016,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L49,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L50,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,84,Male,,1/1/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L51,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Female,,1/1/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L52,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8,74022128,,74022128,,00885556170564,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L53,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,64,Female,,1/1/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L54,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,69,Female,,1/1/2016,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L55,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,55,Male,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L56,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,49,Male,,1/1/2017,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L57,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Male,,1/1/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L58,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability, patella problems, wrong size of femoral component, wrong size of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Male,,1/1/2017,,E1615,F1905,A24;A2303,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L59,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L60,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,73,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L61,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,57,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L62,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: loosening of the patella, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Female,,1/1/2015,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L63,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,57,Male,,1/1/2016,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L64,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3,74022113,,74022113,,00885556169810,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Female,,1/1/2017,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L65,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 2,74022112,,74022112,,00885556169711,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L66,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L67,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: loosening of the patella, femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Male,,1/1/2016,,E161201;E1615,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L68,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 2,74022112,,74022112,,00885556169711,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L69,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L70,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Male,,1/1/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L71,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,61,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L72,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: joint stiffness/arthrofibrosis, pain of unclear origin, other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Female,,1/1/2016,,E161604;E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L73,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,52,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L74,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L75,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,79,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L76,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: loosening of tibial component, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Male,,1/1/2015,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L77,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Male,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L78,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Female,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L79,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L80,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,79,Female,,1/1/2018,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L81,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability, tibial periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,58,Female,,1/1/2017,,E1615;E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L82,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 2,74022122,,74022122,,00885556170267,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: femoral component malposition, tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,50,Female,,1/1/2016,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L83,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Male,,1/1/2018,,E161604,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L84,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L85,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8,74022128,,74022128,,00885556170564,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: pain of unclear origin, other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Male,,1/1/2018,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L86,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems, tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,64,Female,,1/1/2016,,E2401,F1905,A24;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L87,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Male,,1/1/2017,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L88,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Male,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L89,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,85,Male,,1/1/2017,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L90,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L91,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L92,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: loosening of tibial component, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Female,,1/1/2017,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L93,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems, pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,70,Male,,1/1/2016,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L94,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Male,,1/1/2016,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L95,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Male,,1/1/2017,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L96,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Female,,1/1/2017,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L97,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,70,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L98,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: loosening of the patella, femorotibial instability, patellar instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,57,Female,,1/1/2018,,E161201;E1615,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L99,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,54,Female,,1/1/2017,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L100,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems, pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,72,Female,,1/1/2016,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L101,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8,74022128,,74022128,,00885556170564,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,51,Male,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L102,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L103,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: femorotibial instability, wear of inlay.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,69,Male,,1/1/2016,,E1615,F1905,A24;A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L104,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: loosening of tibial component, joint stiffness/arthrofibrosis, pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,61,Male,,1/1/2018,,E161201;E161604;E1601,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L105,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3,74022113,,74022113,,00885556169810,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,78,Female,,1/1/2016,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L106,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: loosening of tibial component, femoral component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,70,Female,,1/1/2017,,E161201;E2308,F1905,A0103;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L107,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,73,Male,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L108,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Female,,1/1/2017,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L109,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L110,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,72,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L111,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,69,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L112,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: loosening of the patella, femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,52,Female,,1/1/2015,,E161201;E1615,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L113,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,52,Female,,1/1/2017,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L114,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,65,Male,,1/1/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L115,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: femoral component malposition, tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Female,,1/1/2015,,E2308,F1905,A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L116,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability, tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Male,,1/1/2018,,E1615;E2308,F1905,A24;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L117,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Female,,1/1/2018,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L118,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,55,Female,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L119,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: patellar periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,54,Female,,1/1/2019,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L120,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Male,,1/1/2018,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L121,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L122,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,70,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L123,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Male,,1/1/2019,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L124,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Female,,1/1/2017,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L125,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,83,Female,,1/1/2019,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L126,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: femorotibial instability, patella problems, femoral component malposition, tibial component malposition, pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,78,Female,,1/1/2016,,E1615;E2308;E1601,F1905,A24;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L127,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L128,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2014 due to: other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,73,Female,,1/1/2014,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L129,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8,74022128,,74022128,,00885556170564,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2014 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Female,,1/1/2014,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L130,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,69,Female,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L131,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Male,,1/1/2018,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L132,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Female,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L133,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,69,Female,,1/1/2018,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L134,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Female,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L135,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems, patellar periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,80,Male,,1/1/2018,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L136,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3,74022113,,74022113,,00885556169810,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,70,Female,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L137,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,54,Male,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L138,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L139,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2013 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Male,,1/1/2013,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L140,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Male,,1/1/2015,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L141,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Male,,1/1/2019,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L142,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3,74022113,,74022113,,00885556169810,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems, patellar periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Female,,1/1/2018,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L143,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,37,Male,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L144,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3,74022113,,74022113,,00885556169810,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems, pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,59,Female,,1/1/2015,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L145,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L146,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L147,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L148,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,51,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L149,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,64,Female,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L150,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2014 due to: patella problems, patellar periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,58,Male,,1/1/2014,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L151,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,57,Female,,1/1/2019,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L152,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8,74022128,,74022128,,00885556170564,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,48,Male,,1/1/2019,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L153,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L154,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,55,Female,,1/1/2019,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L155,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Male,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L156,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L157,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Male,,1/1/2019,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L158,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Male,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L159,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,77,Female,,1/1/2015,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L160,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,72,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L161,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: wrong size of femoral component, joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Male,,1/1/2019,,E161604,F1905,A2303;A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L162,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,57,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L163,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Male,,1/1/2020,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L164,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Female,,1/1/2017,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L165,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,61,Female,,1/1/2019,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L166,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Female,,1/1/2019,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L167,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3,74022113,,74022113,,00885556169810,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: femorotibial instability, joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,58,Female,,1/1/2019,,E1615;E161604,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L168,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,59,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L169,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Female,,1/1/2019,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L170,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,46,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L171,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,54,Male,,1/1/2019,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L172,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patellar instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Female,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L173,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Female,,1/1/2018,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L174,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL COCR RIGHT SIZE 3,74024213,,74024213,,00885556170762,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Female,,1/1/2020,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L175,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2014 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,73,Male,,1/1/2014,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L176,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2021 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Female,,1/1/2021,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L177,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: patella problems, pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Female,,1/1/2019,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L178,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2021 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Male,,1/1/2021,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L179,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: loosening of femoral component, loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,59,Male,,1/1/2019,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L180,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems, other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,65,Male,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L181,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL COCR LEFT SIZE 4,74024924,,74024924,,00885556611425,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2021 due to: infection, other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Female,,1/1/2021,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L182,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems, other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L183,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Male,,1/1/2020,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L184,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 7,74022117,,74022117,,00885556170014,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: femorotibial instability, joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,47,Female,,1/1/2020,,E1615;E161604,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L185,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Female,,1/1/2016,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L186,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability, femoral component malposition, tibial component malposition, joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,72,Female,,1/1/2017,,E1615;E2308;E161604,F1905,A24;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L187,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2021 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,50,Female,,1/1/2021,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L188,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Female,,1/1/2015,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L189,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,55,Female,,1/1/2018,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L190,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Female,,1/1/2020,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L191,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,72,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L192,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,61,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L193,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL COCR RIGHT SIZE 7,74024217,,74024217,,00885556170960,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2021 due to: loosening of tibial component, femorotibial instability, femoral component malposition, tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,58,Male,,1/1/2021,,E161201;E1615;E2308,F1905,A0103;A24;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L194,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: femorotibial instability, other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Female,,1/1/2019,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L195,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,73,Male,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L196,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: joint stiffness/arthrofibrosis, pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Female,,1/1/2019,,E161604;E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L197,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 3,74022123,,74022123,,00885556170311,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: femorotibial instability, wrong size of femoral component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Female,,1/1/2019,,E1615,F1905,A24;A2303,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L198,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,61,Male,,1/1/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L199,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Female,,1/1/2020,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L200,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L201,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: femorotibial instability, joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Female,,1/1/2018,,E1615;E161604,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L202,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 2,74022112,,74022112,,00885556169711,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L203,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L204,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability, tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Female,,1/1/2017,,E1615;E2308,F1905,A24;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L205,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2021 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,51,Female,,1/1/2021,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L206,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 8,74022128,,74022128,,00885556170564,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: patella problems, pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,73,Male,,1/1/2020,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L207,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems, progression of osteoarthritis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,82,Female,,1/1/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L208,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: femoral periprosthetic fracture.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,71,Male,,1/1/2020,,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L209,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,65,Female,,1/1/2019,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L210,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Female,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L211,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2022 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Female,,1/1/2022,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L212,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 7,74022127,,74022127,,00885556170519,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,51,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L213,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL COCR LEFT SIZE 6,74024926,,74024926,,00885556611449,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2023 due to: other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,59,Male,,1/1/2023,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L214,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L215,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,70,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L216,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 3,74022113,,74022113,,00885556169810,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Female,,1/1/2017,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L217,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: patellar instability, progression of osteoarthritis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Female,,1/1/2020,,E1602;E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L218,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,73,Male,,1/1/2019,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L219,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Male,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L220,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,52,Male,,1/1/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L221,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2016 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,75,Male,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L222,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 8,74022118,,74022118,,00885556170069,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: wear of inlay.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Male,,1/1/2017,,E2401,F1905,A040503,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L223,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 9,74022129,,74022129,,00885556170618,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2017 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,59,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L224,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: infection, femoral component malposition, tibial component malposition.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Female,,1/1/2019,,E1906;E2308,F1905,A24;A150202,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L225,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L226,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2024 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,57,Male,,1/1/2024,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L227,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Female,,1/1/2015,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L228,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 4,74022124,,74022124,,00885556170366,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,67,Female,,1/1/2020,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L229,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,69,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L230,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 5,74022115,,74022115,,00885556169919,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2014 due to: other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Female,,1/1/2014,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L231,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2023 due to: infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,54,Female,,1/1/2023,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L232,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Male,,1/1/2020,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L233,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2018 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Male,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L234,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2015 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,64,Male,,1/1/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L235,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 6,74022126,,74022126,,00885556170465,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: femorotibial instability, patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,56,Female,,1/1/2019,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L236,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 6,74022116,,74022116,,00885556169964,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: loosening of femoral component, loosening of tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,66,Male,,1/1/2019,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L237,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM LEFT SIZE 5,74022125,,74022125,,00885556170410,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2020 due to: patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,70,Female,,1/1/2020,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00280093-1-L238,,10/13/2025,5/27/2025,JOURNEY II BCS,JOURNEY II BCS FEMORAL OXINIUM RIGHT SIZE 4,74022114,,74022114,,00885556169865,K111711,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, one (1) knee was revised in 2019 due to: loosening of the patella.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of two thousand two hundred and forty-six (2,246) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II BCS Femoral Component. From these, two hundred and thirty-eight (238) knees were later revised due to the following reasons: two (2) knees due to loosening of the femoral component, twenty-two (22) knees due to loosening of the tibial component, nineteen (19) knees due to loosening of the patellar component, twenty-eight (28) knees due to infection, forty-eight (48) knees due to femorotibial instability, five (5) knees due to patella instability, one hundred nine (109) knees due to patella problems, nine (9) knees due to femoral component malposition, thirteen (13) knees due to tibial component malposition, four (4) knees due to wrong size femoral component, one (1) knee due to wrong size tibial component, eleven (11) knees due to joint stiffness / arthrofibrosis, two (2) knees due to wear of inlay, two (2) knees due to femoral periprosthetic fracture, two (2) knees due to tibial periprosthetic fracture, four (4) knees due to patella periprosthetic fracture, sixteen (16) knees due to pain of unclear origin, two (2) knees due to progression of osteoarthritis and seventeen (17) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure. ;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II BCS Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of two thousand two hundred and forty-six (2,246) primary TKA procedures with Journey II BCS Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. The report captured data stratified by use with/without patella as well as by material (Oxinium/CoCr). Overall, Oxinium femoral components were mostly used. Kaplan-Meier estimates of first revision rates with 95% confidence intervals, revisions per 100 component years and implant usage are presented below for each combination: ;;1. Journey II BCS Oxinium with patellar resurfacing: 1,580 implantations with 132 revisions documented. Revisions per 100 component years: 1.37 (CI: 1.16 - 1.62) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). ;;¿ At 1st postoperative year: 2.5% (1.9%¿3.5%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 5.5% (4.5%¿6.8%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 6.9% (5.7%¿8.2%) vs 3.4% (3.3%¿3.6%) of the class.;¿ At 5th postoperative year: 8.1% (6.8%¿9.6%) vs 4.4% (4.3%¿4.6%) of the class.;¿ At 7th postoperative year: 9.0% (7.6%¿10.6%) vs 5.3% (5.1%¿5.5%) of the class.;¿ At 9th postoperative year: 9.3% (7.8%¿11.0%) vs 6.1% (5.8%¿6.4%) of the class.;¿ At 10th postoperative year: 9.3% (7.8%¿11.0%) vs 6.2% (6.2%¿6.7%) of the class.;;2. Journey II BCS Oxinium without patellar resurfacing: 531 implantations with 102 revisions documented. Revisions per 100 component years: 2.99 (CI: 2.47 - 3.62) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). ;;¿ At 1st postoperative year: 5.9% (4.2%¿8.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 10.7% (8.3%¿13.6%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.8% (9.4%¿14.9%) vs 3.2% (3.1%¿3.3%) of the class.;¿ At 5th postoperative year: 14.9% (12.1%¿18.2%) vs 4.2% (4.0%¿4.3%) of the class.;¿ At 7th postoperative year: 19.3% (16.1%¿23.1%) vs 4.9% (4.8%¿5.1%) of the class.;¿ At 9th postoperative year: 20.8% (17.3%¿24.8%) vs 5.7% (5.5%¿5.8%) of the class.;¿ At 10th postoperative year: 25.9% (19.1%¿34.6%) vs 6.0% (5.8%¿6.2%) of the class.;;3. Journey II BCS Cobalt-Chromium (CoCr) with patellar resurfacing: 106 implantations with 1 revision documented. Revisions per 100 component years: 0.80 (CI: 0.83 - 0.90) vs 0.87 (CI: 0.83 ¿ 0.90) of the class (Cemented TKA with patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 1.0% (0.1%¿6.9%) vs 1.3% (1.2%¿1.4%) of the class.;¿ At 2nd postoperative year: 1.0% (0.1%¿6.9%) vs 2.6% (2.5%¿2.8%) of the class.;¿ At 3rd postoperative year: 1.0% (0.1%¿6.9%) vs 3.4% (3.3%¿3.6%) of the class.;;4. Journey II BCS CoCr without patellar resurfacing: 29 implantations with 3 revisions documented. Revisions per 100 component years: 4.29 (CI: 1.47 - 11.88) vs 1.06 (CI: 1.04 ¿ 1.09) of the class (Cemented TKA without patellar resurfacing). Data is available for only 3 years of follow up.;;¿ At 1st postoperative year: 11.0% (3.7%¿30.3%) vs 1.2% (1.2%¿1.3%) of the class.;¿ At 2nd postoperative year: 11.0% (3.7%¿30.3%) vs 2.5% (2.4%¿2.5%) of the class.;¿ At 3rd postoperative year: 11.0% (3.7%¿30.3%) vs 3.2% (3.1%¿3.3%) of the class.;;Revisions per 100 component years for JOURNEY II BCS for current on-label use with patella resurfacing has strongly improved in Switzerland. JOURNEY II BCS CoCr with patella shows 0.80 which is full in line with the class (0.87). One hundred (100) implantations occurred with a single revision in the first year after implantation being reported. For JOURNEY II BCS Oxinium the value reported is 1.37, which represents a substantial improvement from the 2.02 value previously reported by SIRIS in 2022. Similarly, the cumulative revision rates have lowered, although they remain above the class.;JOURNEY II BCS Oxinium and CoCr with patella resurfacing were implanted in patients with a mean age of 65.6 and 63.0 years, compared to 68.4 for the class. A younger patients¿ population may contribute to higher revision rates. However, Cox proportional hazard ratio adjusted for age, BMI, sex, Charnley restriction, and ASA morbidity still shows a lower survivorship for JOURNEY II BCS Oxinium with patella resurfacing when compared to the class (HR 1.52, p=0.000, 95% CIs (1.236, 1.866)). To better understand which other confounding factors may contribute to this remaining difference for JOURNEY II BCS Oxinium with patella resurfacing, and to visualize the most current performance of the device, the registry report provided analysis of Kaplan Meier estimates of first revision rates restricted to the last 3-years with 95% confidence intervals: ;;1. Journey II BCS Oxinium with patellar resurfacing.;;¿ At 1st postoperative year: 1.1% (0.1%¿7.2%) vs 1.4% (1.2%¿1.5%) of the class.;¿ At 2nd postoperative year: 3.4% (1.1%¿10.1%) vs 2.5% (2.3%¿2.8%) of the class.;¿ At 3rd postoperative year: 3.4% (1.1%¿10.1%) vs 3.3% (3.0%¿3.7%) of the class.;;All implantations captured in the past 3 years by SIRIS for JOURNEY II BCS Oxinium were with patella resurfacing, on-label with current indications. The data show a clear improvement in performance for the system compared to the previous years, with revision rates in line with the class. The difference is likely to be accounted for by usage only with patella coupled to other confounding factors which may include improved training material and surgical instructions.;;Overall, data from the SIRIS registry report show that JOURNEY II BCS CoCr with patella resurfacing is performing in line with the class. JOURNEY II BCS Oxinium with patella resurfacing also showed great improvement in performance. While its overall survivorship remained below the class mean value, survivorship over the past 3-years was instead in line with the class. Confounding factors related to older implantations such as improvement in quality of training and surgical instructions over the years may contribute to this difference. Based on current performance, the subject devices are considered to be state of the art as in line with the class.;;Based also on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,55,Female,,1/1/2019,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,1;CASE-2025-00291866-1-L1,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 6,74021156,,74021156,,00885556422830,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2017 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,77,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L2,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 6,74021156,,74021156,,00885556422830,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2019 due to infection.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Male,,1/1/2019,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L3,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 6,74021156,,74021156,,00885556422830,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2016 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,64,Female,,1/1/2016,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L4,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 5,74021155,,74021155,,00885556422847,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2016 due to femorotibial instability.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Female,,1/1/2016,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L5,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 2,74021152,,74021152,,00885556531884,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2018 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,74,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L6,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS LEFT SIZE 7,74021167,,74021167,,00885556422762,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2018 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,62,Male,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L7,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 3,74021153,,74021153,,00885556422861,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2018 due to patella problems, component malposition - femoral component and component malposition - tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,60,Female,,1/1/2018,,E2401;E2308,F1905,A24;A150202,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L8,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL COCR NONPOROUS LEFT SIZE 6,74021266,,74021266,,00885556615270,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2021 due to other.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,59,Male,,1/1/2021,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L9,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 5,74021155,,74021155,,00885556422847,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2020 due to pain of unclear origin.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,63,Female,,1/1/2020,,E1601,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L10,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS LEFT SZ 9,74021169,,74021169,,00885556531952,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2017 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Male,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L11,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL COCR NONPOROUS LT SZ 5,74021265,,74021265,,00885556615263,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2021 due to loosening - femoral component and loosening - tibial component.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,51,Male,,1/1/2021,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L12,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS LEFT SIZE 6,74021166,,74021166,,00885556422779,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2018 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,61,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L13,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 7,74021157,,74021157,,00885556422823,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2021 due to loosening - patella component and other-unknown reasons.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Male,,1/1/2021,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L14,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 5,74021155,,74021155,,00885556422847,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2017 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,73,Female,,1/1/2017,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L15,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL COCR NONPOROUS RIGHT SIZE 5,74021255,,74021255,,00885556615171,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2021 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,76,Male,,1/1/2021,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L16,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 6,74021156,,74021156,,00885556422830,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2020 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,68,Male,,1/1/2020,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L17,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 5,74021155,,74021155,,00885556422847,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2022 due to femorotibial instability and joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,57,Female,,1/1/2022,,E1615;E161604,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L18,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS LEFT SZ 4,74021164,,74021164,,00885556422793,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2018 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,55,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L19,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 4,74021154,,74021154,,00885556422854,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2022 due to patella problems and joint stiffness/arthrofibrosis.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,55,Female,,1/1/2022,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L20,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 5,74021155,,74021155,,00885556422847,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2017 due to femorotibial instability and patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,53,Female,,1/1/2017,,E1615;E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L21,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 5,74021155,,74021155,,00885556422847,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2018 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,59,Male,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2025-00291866-1-L22,,10/28/2025,5/27/2025,JOURNEY II CR System,JOURNEY II CR FEMORAL OXINIUM NONPOROUS RIGHT SIZE 3,74021153,,74021153,,00885556422861,K121443,,IN,"It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II CR Femoral Component. From these, one (1) knee was revised in 2018 due to patella problems.","Reporting Quarter: 2 (April 1 - June 30, 2025);;Summary of adverse events: It was reported that, in the Swiss Implant Registry (SIRIS) from Switzerland, a total of three hundred eighty-six (386) knees underwent primary TKA procedures between 01-Jan-2012 and 31-Mar-2025, using a Journey II Cruciate Retaining (CR) Femoral Component. From these, twenty two (22) knees were later revised due to the following reasons: one (1) knee due to loosening of the femoral component, one (1) knee due to loosening of the tibial component, one (1) knee due to loosening of the patellar component, one (1) knee due to infection, three (3) knees due to femorotibial instability, fifteen (15) knees due to patella problems, one (1) knee due to femoral component malposition, one (1) knee due to tibial component malposition, two (2) knees due to joint stiffness / arthrofibrosis, one (1) knee due to pain of unclear origin and two (2) knees due to other-unknown reasons. It should be noted that more than one reason for revision may be listed for a single revision procedure.;Timeframe of Registry data: Implantations conducted between 01-Jan-2012 and 31-Mar-2025 in Switzerland. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II CR Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;;According to this registry report, a total of three hundred eighty-six (386) primary TKA procedures with Journey II CR Femoral components were performed in Switzerland between 01-Jan-2012 and 31-Mar-2025. Kaplan-Meier estimates of first revision rates of any component were in line with the TKA class based on overlapping confidence intervals. The following cumulative revision rates with 95% confidence intervals are presented in this report: ;;¿ At 1st postoperative year: 1.0% (0.4%¿2.8%) vs 1.6% (1.5%¿1.6%) of the class.;¿ At 2nd postoperative year: 3.2% (1.7%¿5.5%) vs 3.3% (3.2%¿3.4%) of the class.;¿ At 3rd postoperative year: 3.8% (2.2%¿6.3%) vs 4.3% (4.2%¿4.4%) of the class.;¿ At 5th postoperative year: 5.5% (3.4%¿8.7%) vs 5.5% (5.4%¿5.6%) of the class.;¿ At 7th postoperative year: 9.0% (5.6%¿14.3%) vs 6.5% (6.3%¿6.6%) of the class.;;The analysis in the report was provided in cohorts based on patella management. The patella was resurfaced in 261 knees while the remaining 125 knees had no patella resurfacing during primary TKA. Further stratification is provided based on the femoral component material used during primary TKA. From the 261 knees with patellar resurfacing at primary, 255 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 6 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component. For the 125 knees without patella resurfacing at primary, 103 knees were replaced using a Journey II CR Oxinium femoral component while the remaining 22 knees were replaced using a Journey II Cobalt-Chromium (CoCr) femoral component;The mean follow-up of JOURNEY II CR OXINIUM was 4.23 years (range: 0.04-9.38 years) with patella and 6.31 years (range: 0.58-9.04 years) without patella. The mean age of patients when implanted with JOURNEY II CR OXINIUM with patella (65.5 years; range: 31-88 years) was younger than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR OXINIUM without patella (67.1 years; range: 39-86 years) was younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR OXINIUM with patella was 50.6% male while JOURNEY II CR OXINIUM without patella was 48.5% male.;;The mean follow-up of JOURNEY II CR Cobalt-Chromium (CoCr) was 3.67 years (range: 0.99-4.8 years) with patella and 3.80 years (range: 0.00-5.32 years) without patella. The mean age of patients when implanted with JOURNEY II CR CoCr with patella (76.5 years; range: 51-89 years) was older than the TKA class with patella (69.8 years, range: 13-102 years). The mean age of patients when implanted with JOURNEY II CR CoCr without patella (69.3 years; range: 54-85 years) was slightly younger than the TKA class without patella (69.6 years, range: 11-102 years). JOURNEY II CR CoCr with patella was 66.7% male while JOURNEY II CR CoCr without patella was 31.8% male.;;Revision rates per 100 component years at first revision are available and further stratified by femoral component variant and by patella resurfacing at primary TKA. There is no statistically significant difference from the respective TKA class for with and without patella resurfacing at primary TKA for both Journey II CR Oxinium and CoCr femoral components based on non-overlapping of confidence intervals. However, the confidence intervals are wide due to the low number of implantations. Further, low implantation numbers decrease the accuracy of the revision rates. Cox proportional hazard ratios adjusted for age (continuous), BMI (continuous), sex, Charnley restriction and ASA morbidity are also presented in the ad-hoc SIRIS report. The Journey II CR system presented a hazard ratio of 0.95 (p value: 0.833; 95% CIs: 0.607-1.495) when compared to the SIRIS TKA class. As a result, there was no statistically significant difference between the Journey II CR system and the TKA class. ;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ; ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",,59,Female,,1/1/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE SWISS NATIONAL JOINT REGISTRY (SIRIS), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN SWITZERLAND FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY TKA JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - JOURNEY II BCS FEMORAL COMPONENT: A TOTAL OF TWO THOUSAND TWO HUNDRED AND FORTY-SIX (2,246) KNEES UNDERWENT PRIMARY TKA PROCEDURES BETWEEN 01-JAN-2012 AND 31-MAR-2025. FROM THESE, TWO HUNDRED AND THIRTY-EIGHT (238) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWO (2) KNEES DUE TO LOOSENING OF THE FEMORAL COMPONENT, TWENTY-TWO (22) KNEES DUE TO LOOSENING OF THE TIBIAL COMPONENT, NINETEEN (19) KNEES DUE TO LOOSENING OF THE PATELLAR COMPONENT, TWENTY-EIGHT (28) KNEES DUE TO INFECTION, FORTY-EIGHT (48) KNEES DUE TO FEMOROTIBIAL INSTABILITY, FIVE (5) KNEES DUE TO PATELLA INSTABILITY, ONE HUNDRED NINE (109) KNEES DUE TO PATELLA PROBLEMS, NINE (9) KNEES DUE TO FEMORAL COMPONENT MALPOSITION, THIRTEEN (13) KNEES DUE TO TIBIAL COMPONENT MALPOSITION, FOUR (4) KNEES DUE TO WRONG SIZE FEMORAL COMPONENT, ONE (1) KNEE DUE TO WRONG SIZE TIBIAL COMPONENT, ELEVEN (11) KNEES DUE TO JOINT STIFFNESS / ARTHROFIBROSIS, TWO (2) KNEES DUE TO WEAR OF INLAY, TWO (2) KNEES DUE TO FEMORAL PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO TIBIAL PERIPROSTHETIC FRACTURE, FOUR (4) KNEES DUE TO PATELLA PERIPROSTHETIC FRACTURE, SIXTEEN (16) KNEES DUE TO PAIN OF UNCLEAR ORIGIN, TWO (2) KNEES DUE TO PROGRESSION OF OSTEOARTHRITIS AND SEVENTEEN (17) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MORE THAN ONE REASON FOR REVISION MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 238 REVISIONS HAS BEEN REPORTED IN SIRIS FOR THE JOURNEY II BCS FEMORAL COMPONENT.

Description of Event or Problem · 0

BASED ON REAL WORLD DATA FROM THE SWISS NATIONAL JOINT REGISTRY (SIRIS), SEVERAL REVISION SURGERIES HAVE BEEN REPORTED IN SWITZERLAND FOLLOWING THE USE OF SMITH+NEPHEW PROSTHESES IN PRIMARY TOTAL KNEE ARTHROPLASTY (TKA) JOINT REPLACEMENT PROCEDURES: 1. PRIMARY TKA PROCEDURES: - JOURNEY II BI-CRUCIATE STABILIZED (BCS) FEMORAL COMPONENT: A TOTAL OF TWO THOUSAND TWO HUNDRED AND FORTY-SIX (2,246) KNEES UNDERWENT PRIMARY TKA PROCEDURES BETWEEN 01-JAN-2012 AND 31-MAR-2025. FROM THESE, TWO HUNDRED AND THIRTY-EIGHT (238) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: TWO (2) KNEES DUE TO LOOSENING OF THE FEMORAL COMPONENT, TWENTY-TWO (22) KNEES DUE TO LOOSENING OF THE TIBIAL COMPONENT, NINETEEN (19) KNEES DUE TO LOOSENING OF THE PATELLAR COMPONENT, TWENTY-EIGHT (28) KNEES DUE TO INFECTION, FORTY-EIGHT (48) KNEES DUE TO FEMOROTIBIAL INSTABILITY, FIVE (5) KNEES DUE TO PATELLA INSTABILITY, ONE HUNDRED NINE (109) KNEES DUE TO PATELLA PROBLEMS, NINE (9) KNEES DUE TO FEMORAL COMPONENT MALPOSITION, THIRTEEN (13) KNEES DUE TO TIBIAL COMPONENT MALPOSITION, FOUR (4) KNEES DUE TO WRONG SIZE FEMORAL COMPONENT, ONE (1) KNEE DUE TO WRONG SIZE TIBIAL COMPONENT, ELEVEN (11) KNEES DUE TO JOINT STIFFNESS / ARTHROFIBROSIS, TWO (2) KNEES DUE TO WEAR OF INLAY, TWO (2) KNEES DUE TO FEMORAL PERIPROSTHETIC FRACTURE, TWO (2) KNEES DUE TO TIBIAL PERIPROSTHETIC FRACTURE, FOUR (4) KNEES DUE TO PATELLA PERIPROSTHETIC FRACTURE, SIXTEEN (16) KNEES DUE TO PAIN OF UNCLEAR ORIGIN, TWO (2) KNEES DUE TO PROGRESSION OF OSTEOARTHRITIS AND SEVENTEEN (17) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS FOR REVISION MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. - JOURNEY II CRUCIATE-RETAINING (CR) FEMORAL COMPONENT: IMPLANTED IN THREE HUNDRED EIGHTY-SIX (386) KNEES BETWEEN 01-JAN-2012 AND 31-MAR-2025. FROM THESE, TWENTY TWO (22) KNEES WERE LATER REVISED DUE TO THE FOLLOWING REASONS: ONE (1) KNEE DUE TO LOOSENING OF THE FEMORAL COMPONENT, ONE (1) KNEE DUE TO LOOSENING OF THE TIBIAL COMPONENT, ONE (1) KNEE DUE TO LOOSENING OF THE PATELLAR COMPONENT, ONE (1) KNEE DUE TO INFECTION, THREE (3) KNEES DUE TO FEMOROTIBIAL INSTABILITY, FIFTEEN (15) KNEES DUE TO PATELLA PROBLEMS, ONE (1) KNEE DUE TO FEMORAL COMPONENT MALPOSITION, ONE (1) KNEE DUE TO TIBIAL COMPONENT MALPOSITION, TWO (2) KNEES DUE TO JOINT STIFFNESS / ARTHROFIBROSIS, ONE (1) KNEE DUE TO PAIN OF UNCLEAR ORIGIN AND TWO (2) KNEES DUE TO OTHER-UNKNOWN REASONS. IT SHOULD BE NOTED THAT MULTIPLE REASONS FOR REVISION MAY BE LISTED FOR A SINGLE REVISION PROCEDURE. ALTOGETHER, A TOTAL QUANTITY OF 260 REVISIONS HAVE BEEN REPORTED IN SIRIS FOR THE JOURNEY II TOTAL KNEE SYSTEMS REFERENCED ABOVE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
185094		PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL	JWH	SMITH & NEPHEW, INC.

Patients

Seq	Age	Sex	Outcome	Treatment
1	64 YR	Unknown

Terms

Patient problem · 9

• Arthralgia
• Arthritis
• Arthrofibrosis
• Aseptic loosening
• Deformity/ Disfigurement
• Insufficient Information
• Joint Laxity
• Periprosthetic fracture
• Unspecified Infection

Product problems · 5

• Adverse Event Without Identified Device or Use Problem
• Improper or Incorrect Procedure or Method
• Loosening of Implant Not Related to Bone-Ingrowth
• Malposition of Device
• Material Erosion

Source type · 1

• Other

Type of report · 2

• Followup
• Initial submission