BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK REVISION TOTAL KNEE SYSTEM

    MDR report key: 24078373 · Received January 15, 2026

    Report

    Report Number
    3005180920-2026-00036
    Event Type
    Injury
    Date Received
    January 15, 2026
    Date of Event
    January 6, 2026
    Report Date
    January 15, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819391
    PMA / PMN Number
    K123721
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEWS PERFORMED ON 07-JAN-26. GMK-REVISION 02.07.0684R REVISION TIBIAL TRAY SIZE 4 RIGHT (K123721) LOT. 189502: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-FEB-2019 EXPIRATION DATE: 2024-02-07. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. GMK-REVISION 02.07.2405R FEMUR REVISION PS CEMENTED S.5R (K102437) LOT. 1900614: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-JUL-2019 EXPIRATION DATE: 2024-07-06. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: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 HAD PRIMARY RIGHT KNEE SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2019, THE PATIENT WAS REVISED FROM THE COMPETITOR IMPLANTS TO MEDACTA IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO INSTABILITY AS A RESULT OF THE LOOSENING IMPLANTS OF THE TIBIA AND FEMUR. THE SURGEON REVISED THE FEMUR, TRAY, AND INSERT TO A GMK-HINGE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145796 GMK REVISION TOTAL KNEE SYSTEM REVISION TIBIAL TRAY SIZE 4 RIGHT JWH MEDACTA INTERNATIONAL SA 02.07.0684R 189502 07630030819391

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention