BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK IMPLANTS

    MDR report key: 23299144 · Received October 15, 2025

    Report

    Report Number
    3005180920-2025-00988
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    September 24, 2025
    Report Date
    October 14, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 25-SEPTEMBER-2025. GMK-SPHERE 02.07.1202L TIBIAL TRAY FIX CEMENTED S.2L LOT. 2241999: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEBRUARY-2023.EXPIRATION DATE: 18-JANUARY-2028. 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. CONCLUSIONS: ASEPTIC LOOSENING IS A POSSIBLE LITERATURE-DESCRIBED ADVERSE EVENT AFTER PRIMARY KNEE ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AFTER 2 YEARS AND 6 MONTHS FROM THE PRIMARY SURGERY, THE PATIENT PRESENTED WITH LOOSENING OF THE TIBIAL TRAY. THERE WAS NO LOOSENING OF THE FEMORAL COMPONENT. THE SURGEON REVISED THE TIBIAL TRAY AND INSERT WITH A GMK-REVISION TIBIAL TRAY WITH WEDGES, OFFSET, AND EXTENSION STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2536101 GMK IMPLANTS TIBIAL TRAY FIX CEMENTED S.2L JWH MEDACTA INTERNATIONAL SA 02.07.1202L 2241999 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Female Required Intervention