PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER
Received Jul 22, 2026
Report 1020279-2026-01011 · MDR key 25905930
Device
Generic name
Prosthesis, Knee, Femorotibial, Non-constrained, Cemented, Metal/polymer
Manufacturer
Smith & Nephew, Inc.Product problems
- Material Erosion
- Fracture
- Device Dislodged or Dislocated
- Adverse Event Without Identified Device or Use Problem
- Loosening of Implant Not Related to Bone-Ingrowth
Patient
64 YR · Unknown
- Arthritis
- Unspecified Infection
- Pain
- Loss of Range of Motion
- Deformity/ Disfigurement
- Joint Dislocation
- Osteolysis
- Joint Laxity
- Insufficient Information
- Aseptic loosening
- Periprosthetic fracture
Narrative
Description of Event or Problem
Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;CASE-2026-00324460-1-L1,4/13/2018,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI ALLPOLY TIB SZ 6 LM/RL 7MM,71422406,10cm08383,71422406,,03596010593610,K230653,,IN,"It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eleven (11) knees underwent primary UKR between 24-Apr-2012 and 11-Jan-2024 in which a JOURNEY UNI All Poly Tibial Component was implanted. Of these, one (1) knee required revision due to progressive arthritis. ","Reporting Quarter: 2 (April 1 ¿ June 30, 2026);Summary of adverse events: It was reported that, based on the data gathered by the National Joint Registry (NJR), a total of eleven (11) knees underwent primary UKR between 24-Apr-2012 and 11-Jan-2024 in which a JOURNEY UNI All Poly Tibial Component was implanted. Of these, one (1) knee required revision due to progressive arthritis.;Timeframe of Registry Data: Implantations conducted between 24-Apr-2012 and 11-Jan-2024 in United Kingdom;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY UNI Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of eleven (11) knees underwent primary UKR in which a JOURNEY UNI All Poly Tibial Component was implanted in United Kingdom between 24-Apr-2012 and 11-Jan-2024. ;Due to the low number of implantations for the JOURNEY UNI All Poly Tibial Components, the cumulative percent revision rates could not be reliably calculated. However, with only one revision reported throughout twelve years, the safety benchmark is considered to have been met.;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.",Osteoarthritis,52,Male,,1/25/2013,4/13/2018,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L1,9/14/2022,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 6,71422436,11DM16081A,71422436,,00885556088395,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia,Instability,Wear of Polyethylene Component.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,,7/8/2013,9/14/2022,E161201;E1615,F1905,A0103;A24;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L2,9/14/2016,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 5,71422435,12em00262,71422435,,00885556088340,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Male,,7/12/2013,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L3,1/15/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 5,71422435,11em07804,71422435,,00885556088340,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur,Aseptic loosening Tibia,Instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,54,Male,,9/10/2013,1/15/2025,E161201;E1615,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L4,1/12/2019,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,12gm07082,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Male,,11/23/2013,1/12/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L5,3/21/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,3MM06106,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Female,,4/24/2014,3/21/2024,E161201;E1602,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L6,5/5/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 3,71422433,4CM1859,71422433,,00885556088241,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Male,83,6/12/2014,5/5/2023,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L7,7/2/2016,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2,71422422,14bm14375,71422422,,00885556087893,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,69,Male,,6/30/2014,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L8,8/11/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2,71422422,13lm13846,71422422,,00885556087893,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,76,Female,,7/30/2014,8/11/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L9,2/9/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,3MM14952,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Other,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Male,,10/29/2014,2/9/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L10,12/19/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 6,71422426,14BM00778,71422426,,00885556088098,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Male,92,11/24/2014,12/19/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L11,7/12/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 6,71422426,12KM12469R,71422426,,00885556088098,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia,Instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,76,Male,,2/6/2015,7/12/2024,E161201;E1615,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L12,5/17/2017,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 3,71422423,14GM12746,71422423,,00885556087947,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Female,,5/19/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L13,8/19/2015,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,14mm08266,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,43,Male,,7/29/2015,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L14,12/22/2015,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2,71422422,14MM13403,71422422,,00885556087893,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Female,,8/19/2015,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L15,7/23/2019,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 3,71422433,2JM08673,71422433,,00885556088241,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Female,92,9/11/2015,7/23/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L16,12/17/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 3,71422423,15BM07834,71422423,,00885556087947,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,72,Female,,10/17/2015,,E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L17,5/13/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,15fm18751,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Dislocation/Subluxation,Wear of Polyethylene Component,Component Dissociation,Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Male,,11/11/2015,5/13/2024,E1614;E2401;E2127,F1905,A24;A051201;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L18,9/13/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 6,71422426,0000,71422426,,00885556088098,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis; Other.,67,Male,,12/23/2015,9/13/2024,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L19,7/26/2019,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 4,71422424,15CM14237,71422424,,00885556087992,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,46,Female,,2/1/2016,7/26/2019,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L20,1/23/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 4,71422424,15mm00317,71422424,,00885556087992,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,82,Male,,5/5/2016,1/23/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L21,1/3/2020,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 2,71422432,14FM08957,71422432,,00885556088197,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,52,Female,,5/7/2016,1/3/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L22,11/8/2022,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 5,71422435,15mm00323,71422435,,00885556088340,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Lysis Tibia,Instability.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,75,Male,73,6/7/2016,11/8/2022,E1627;E1615,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L23,4/20/2018,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,4DM17296,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,68,Male,,8/25/2016,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L24,4/22/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 5,71422425,15dm15668,71422425,,00885556088043,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Unexplained Pain,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,57,Male,,9/6/2016,4/22/2024,E2330;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L25,9/20/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,16lm04997,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Periprosthetic Fracture,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,52,Male,,2/8/2017,9/20/2024,E2127;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L26,3/13/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 5,71422435,15dm01917,71422435,,00885556088340,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Male,,3/16/2017,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L27,9/16/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 5,71422435,16gm02979,71422435,,00885556088340,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Stiffness.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,79,Male,,4/11/2017,9/16/2025,E1616,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L28,7/16/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 6,71422426,16HM09150,71422426,,00885556088098,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Wear of Polyethylene Component,Component Dissociation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,60,Male,,4/19/2017,7/16/2024,E2401,F1905,A040503;A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L29,5/7/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 3,71422423,17bm05319,71422423,,00885556087947,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,60,Female,,7/4/2017,5/7/2025,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L30,7/20/2022,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 5,71422425,17am04940,71422425,,00885556088043,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Male,,7/7/2017,7/20/2022,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L31,7/24/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 6,71422436,14KM07338,71422436,,00885556088395,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,65,Male,,7/28/2017,7/24/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L32,9/9/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,16CM22089,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Female,,9/29/2017,9/9/2024,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L33,7/17/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 6,71422436,17CM22273,71422436,,00885556088395,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur,Aseptic loosening Tibia,Wear of Polyethylene Component.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Other.,57,Male,79,10/20/2017,7/17/2023,E161201,F1905,A0103;A040503,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L34,12/12/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2,71422422,12lm10512,71422422,,00885556087893,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur,Aseptic loosening Tibia,Lysis Tibia,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,74,Female,,11/2/2017,12/12/2023,E161201;E1627;E1602,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L35,4/13/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 1,71422431,12KM14258,71422431,,00885556088142,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur,Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,58,Female,,1/30/2018,4/13/2023,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L36,1/20/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 3,71422433,16bm19334,71422433,,00885556088241,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Female,,5/23/2018,1/20/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L37,12/13/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 5,71422425,17LM12762,71422425,,00885556088043,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Previous Trauma.,62,Male,92,9/13/2018,12/13/2024,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L38,2/24/2021,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,18bm14468,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Male,,10/17/2018,2/24/2021,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L39,11/28/2022,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 5,71422435,16GM02979,71422435,,00885556088340,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,52,Female,,11/29/2018,11/28/2022,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L40,4/17/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 5,71422425,18dm18235,71422425,,00885556088043,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,47,Female,,12/6/2018,,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L41,1/4/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 3,71422433,17mm11168,71422433,,00885556088241,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,57,Female,95,1/2/2019,1/4/2023,E161201;E1602,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L42,6/23/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 3,71422423,188gm18558,71422423,,00885556087947,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,85,Female,80,1/11/2019,6/23/2023,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L43,3/21/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,18lm14217,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,,1/31/2019,,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L44,12/7/2020,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2,71422422,18LM04766,71422422,,00885556087893,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,57,Female,,3/25/2019,12/7/2020,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L45,11/9/2022,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2,71422422,19am01231,71422422,,00885556087893,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,63,Female,,4/3/2019,11/9/2022,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L46,6/21/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2,71422422,18LM04766,71422422,,00885556087893,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur,Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,69,Female,,4/24/2019,6/21/2025,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L47,2/16/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 3,71422423,18CM01265,71422423,,00885556087947,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Male,,5/16/2019,2/16/2023,E161201;E1602,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L48,2/6/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 3,71422423,19BM02161,71422423,,00885556087947,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Female,,6/5/2019,2/6/2025,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L49,8/12/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2,71422422,19am20018,71422422,,00885556087893,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,69,Female,88,7/22/2019,8/12/2024,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L50,1/9/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 5,71422435,19em21870,71422435,,00885556088340,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,56,Female,,9/18/2019,1/9/2024,E2127,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L51,7/31/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,19gm01728,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Wear of Polyethylene Component,Periprosthetic Fracture,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Female,,10/21/2019,7/31/2025,E2127;E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L52,7/19/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 5,71422435,18HM18392,71422435,,00885556088340,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Male,,1/21/2020,7/19/2025,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L53,1/6/2026,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 5,71422425,19lm07150,71422425,,00885556088043,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Wear of Polyethylene Component,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,55,Male,,3/14/2020,1/6/2026,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L54,7/13/2021,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,19LM00465,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,60,Male,,10/31/2020,7/13/2021,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L55,3/19/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 6,71422426,20CM16634,71422426,,00885556088098,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,67,Male,,11/23/2020,,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L56,10/7/2022,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 4,71422424,20jm07979,71422424,,00885556087992,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Female,,3/16/2021,10/7/2022,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L57,12/4/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 3,71422433,20JM01956,71422433,,00885556088241,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Malalignment,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,81,Female,65,3/16/2021,12/4/2023,E2308;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L58,2/12/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 3,71422423,19GM01726,71422423,,00885556087947,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Wear of Polyethylene Component,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,73,Female,,3/19/2021,2/12/2024,E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L59,9/12/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 2,71422432,20cm16930,71422432,,00885556088197,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,71,Female,,9/30/2021,9/12/2024,E161201;E1602,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L60,9/9/2022,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 5,71422425,21BM10086,71422425,,00885556088043,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia,Unexplained Pain,Malalignment.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,62,Male,,10/7/2021,9/9/2022,E161201;E2330;E2308,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L61,3/1/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 2,71422432,21CM02562,71422432,,00885556088197,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Male,,11/27/2021,3/1/2023,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L62,2/21/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 4,71422424,21km04898,71422424,,00885556087992,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,76,Male,,2/25/2022,2/21/2023,E2401,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L63,11/3/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 3,71422433,21fm23105,71422433,,00885556088241,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Female,,5/9/2022,11/3/2023,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L64,9/30/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 6,71422426,21DM00925,71422426,,00885556088098,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,58,Male,90,6/7/2022,9/30/2024,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L65,2/18/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 3,71422423,22CM09020,71422423,,00885556087947,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur,Aseptic loosening Tibia.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,78,Male,,8/8/2022,2/18/2025,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L66,1/30/2026,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 4,71422434,19gm25314,71422434,,00885556088296,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Wear of Polyethylene Component,Periprosthetic Fracture,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,84,Female,,9/27/2022,1/30/2026,E2127;E1602,F1905,A040503;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L67,12/7/2022,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 4,71422424,22EM06530,71422424,,00885556087992,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Infection,Other.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,66,Male,,10/5/2022,12/7/2022,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L68,2/6/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 5,71422425,20MM05191,71422425,,00885556088043,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,70,Male,85,10/31/2022,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L69,4/4/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 5,71422425,20CM14283,71422425,,00885556088043,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Periprosthetic Fracture,ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,64,Male,,11/3/2022,4/4/2024,E2127;E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L70,4/2/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 2,71422422,20km03475,71422422,,00885556087893,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Unexplained Pain.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Female,,11/22/2022,4/2/2025,E2330,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L71,7/18/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 3,71422423,19JM03229A,71422423,,00885556087947,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Aseptic loosening Femur,Dislocation/Subluxation,Periprosthetic Fracture.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,59,Female,,6/16/2023,7/18/2025,E161201;E1614;E2127,F1905,A0103;A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L72,10/24/2023,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 5,71422435,20MM05189,71422435,,00885556088340,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Component Dissociation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,55,Male,,8/4/2023,10/24/2023,E2401,F1905,A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L73,10/22/2024,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 5,71422425,23BM11564,71422425,,00885556088043,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:ProgressiveAthritis.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,61,Male,,8/31/2023,10/22/2024,E1602,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L74,6/19/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE LEFT MEDIAL/RIGHT LATERAL SIZE 4,71422424,24am07740,71422424,,00885556087992,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Dislocation/Subluxation,Wear of Polyethylene Component,Component Dissociation.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,56,Male,,9/12/2024,6/19/2025,E1614;E2401,F1905,A24;A040503;A051201,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00325093-1-L75,3/4/2025,7/22/2026,4/17/2026,JOURNEY Unicompartmental Knee System ,JOURNEY UNI TIBIAL BASE RIGHT MEDIAL/LEFT LATERAL SIZE 6,71422436,23JM05836,71422436,,00885556088395,K102069,,IN,"It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one (1) knee was later revised due to:Infection.","Reporting Quarter: 2 (April 1 - June 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from the United Kingdom, a total of two thousand six hundred thirty-two (2,632) knees underwent primary UKA procedures between 16-May-2011 and 19-Feb-2026, using JOURNEY UNI Metal-backed tibia component. From these, one hundred twenty-two (122) knees were later revised due to the following complications: forty-two (42) knees due to progressive arthritis of the remaining joint, twenty-nine (29) knees due to aseptic loosening of the tibia, sixteen (16) knees due to aseptic loosening of the femur, fifteen (15) knees due to other-unspecified reasons, fourteen (14) knees due to pain, thirteen (13) knees due to component dissociation, twelve (12) knees due to instability, ten (10) knees due to polyethylene component wear, eight (8) knees due to peri-prosthetic fracture, seven (7) knees due to infection, six (6) knees due to dislocation/subluxation, three (3) knees due to stiffness, two (2) knees due to tibial lysis, two (2) knees due to malalignment, and one (1) knee due to implant fracture. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 16-May-2011 and 19-Feb-2026 in the United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect of the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and risk reduction measures included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users.;According to this registry report, a total of two thousand six hundred thirty-two (2,632) primary UKA procedures with JOURNEY UNI Metal-backed tibia components have been performed in the UK between 16-May-2011 and 19-Feb-2026. ;The cumulative revision rates for JOURNEY UNI with Metal-backed tibia components are in line with the class average, based on overlapping confidence intervals at 10 years of follow-up.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 1.14% (0.8%-1.64%) vs 0.82% (0.77%-0.87%) of the class.;-At 3rd postoperative year: 2.82% (2.22%-3.59%) vs 3.13% (3.03%-3.24%) of the class.;-At 5th postoperative year: 4.01% (3.24%-4.95%) vs 4.83% (4.70%-4.96%) of the class.;-At 10th postoperative year: 8.39% (6.78%-10.36%) vs 9.13% (8.93%-9.33%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks UKAt are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for primary procedure: Osteoarthritis.,56,Male,,2/5/2025,,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00326999-1-L1,10/9/2025,7/22/2026,5/14/2026,JOURNEY II Unicompartmental Knee System,JOURNEY II UNI OXINIUM FEMORAL COMPONENT 4 LM/RL,74026024,22gm04854,74026024,,00885556675779,K190085,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand four hundred twenty (1,420) knees underwent primary UKA between 8-Dec-2021 and 24-Feb-2026, using a JOURNEY II UK femoral component. From these, one (1) knee was later revised due to: Aseptic loosening Tibia","Reporting Quarter: 2 (Apr 1 - Jun 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand four hundred twenty (1,420) knees underwent primary UKA between 8-Dec-2021 and 24-Feb-2026, using a JOURNEY II UK femoral component. From these, two (2) knees were later revised due to the following complications: one (1) knee due to Aseptic Loosening of the Tibia, and one (1) knee due to infection. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 8-Dec-2021 and 24-Feb-2026 in United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand four hundred twenty (1,420) procedures with JOURNEY II UK femoral component have been performed in the United Kingdom between 8-Dec-2021 and 24-Feb-2026. The mean cumulative revision rate for JOURNEY II UK femoral component at 3 years of follow-up is significantly lower than the class based on non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.07% (0.01%-0.51%) vs 0.92% (0.88%-0.96%) of the class.;-At 3rd postoperative year: 0.26% (0.06%-1.17%) vs 3.21% (3.13%-3.29%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for Primary Procedure: Osteoarthritis,78,Female,97,9/2/2024,10/9/2025,E161201,F1905,A0103,G07001,B20;B22,C19,D12;D15,,0;CASE-2026-00326999-1-L2,4/14/2025,7/22/2026,5/14/2026,JOURNEY II Unicompartmental Knee System,JOURNEY II UNI OXINIUM FEMORAL COMPONENT 8 LM/RL,74026028,22gm15851,74026028,,00885556675816,K190085,,IN,"It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand four hundred twenty (1,420) knees underwent primary UKA between 8-Dec-2021 and 24-Feb-2026, using a JOURNEY II UK femoral component. From these, one (1) knee was later revised due to: Infection","Reporting Quarter: 2 (Apr 1 - Jun 30, 2026);;Summary of adverse events: It was reported that, in the National Joint Registry (NJR) from United Kingdom, a total of one thousand four hundred twenty (1,420) knees underwent primary UKA between 8-Dec-2021 and 24-Feb-2026, using a JOURNEY II UK femoral component. From these, two (2) knees were later revised due to the following complications: one (1) knee due to Aseptic Loosening of the Tibia, and one (1) knee due to infection. It should be noted that multiple reasons may be listed for one revision procedure.;Timeframe of Registry data: Implantations conducted between 8-Dec-2021 and 24-Feb-2026 in United Kingdom. ;;Analysis Conducted: Based on the most recent safety and performance evaluation, the JOURNEY II Unicompartmental Knee System presents a favorable benefit/risk assessment when used under the conditions and for the purposes intended by the manufacturer and with respect to the contraindications and precautions for use and warnings described in the information material supplied with the devices. This system is at least as safe and effective as all its therapeutic alternatives in the targeted indication. The intended purpose and information for safety included in the information materials supplied by the manufacturer are adequate and suitable for the intended uses and users. ;According to this registry report, a total of one thousand four hundred twenty (1,420) procedures with JOURNEY II UK femoral component have been performed in the United Kingdom between 8-Dec-2021 and 24-Feb-2026. The mean cumulative revision rate for JOURNEY II UK femoral component at 3 years of follow-up is significantly lower than the class based on non-overlapping confidence intervals.;;The following cumulative revision rates with 95% confidence intervals are presented in this report: ;-At 1st postoperative year: 0.07% (0.01%-0.51%) vs 0.92% (0.88%-0.96%) of the class.;-At 3rd postoperative year: 0.26% (0.06%-1.17%) vs 3.21% (3.13%-3.29%) of the class.;;Based on the review of other clinical sources such as clinical activities, complaint data, published literature and other joint registries, no increased risks to health or an increased trend in any of the adverse events summarized above have been identified. The reported adverse events relate to known inherent procedural risks that are appropriately documented in our risk files. No individual investigations into the reported adverse events are deemed necessary. ;Additional Action(s) taken: No additional actions are deemed necessary at this time. Smith+Nephew will continue to monitor trends in accordance with our post-market surveillance process and take necessary action as required if anticipated severity and/or occurrence rates are exceeded.",Indication for Primary Procedure: Osteoarthritis,81,Male,66,2/25/2025,4/14/2025,E1906,F1905,A24,G07001,B20;B22,C19,D12;D15,,0;