BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TOTAL KNEE SYSTEM

    MDR report key: 23334292 · Received October 20, 2025

    Report

    Report Number
    3005180920-2025-01006
    Event Type
    Injury
    Date Received
    October 20, 2025
    Date of Event
    October 2, 2025
    Report Date
    October 20, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630040711548
    PMA / PMN Number
    K202684
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 9 OCTOBER 2025: GMK-SPHERE 02.12.0723L GMK-SPHERE FEM COMPONENT CEMENTED TINBN COATED 3+L (K202684) LOT 2115647: (B)(4) MANUFACTURED AND RELEASED ON 02-MAY-2022. EXPIRATION DATE: 19-APR-2027. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANT INVOLVED, BATCH REVIEW PERFORMED ON 9 OCTOBER 2025: GMK-SPHERE 02.07.2802L FIXED TIBIAL TRAY SIZE 2 L - TINBN COATING (K202684) LOT 2105135: (B)(4) MANUFACTURED AND RELEASED ON 02-SEP-2021. EXPIRATION DATE: 22-AUG-2026. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CONCLUSION: BASED ON THE INFORMATION AVAILABLE NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED, WHILE THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

    Description of Event or Problem · 0

    THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO LOOSENING OF THE COMPONENTS. ABOUT 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE TRAY, FEMORAL COMPONENT, AND INSERT TO REVISION COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266878 GMK TOTAL KNEE SYSTEM FEMORAL COMPONENT SPHERE SIZE 3+ L TINBN COATED JWH MEDACTA INTERNATIONAL SA 02.12.0723L 2115647 07630040711548

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention