BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 23253200 · Received October 9, 2025

    Report

    Report Number
    3005180920-2025-00964
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 17, 2025
    Report Date
    September 10, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 19 SEPTEMBER 2025: LOT: 2242805: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-FEB-2023. EXPIRATION DATE: 2028-JAN-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. 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 KNEE INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON FOUND ASEPTIC TIBIAL LOOSENING AND AT ABOUT 2 YEARS AND 4 MONTHS POST PRIMARY REVISED THE INSERT, TRAY AND FEMUR TO GMK-REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521916 GMK PRIMARY TOTAL KNEE SYSTEM FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 5 JWH MEDACTA INTERNATIONAL SA 02.07.1205R 2242805

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention