BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 25230404 · Received May 20, 2026

    Report

    Report Number
    3005180920-2026-00439
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 23, 2026
    Report Date
    May 20, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819865
    PMA / PMN Number
    K090988
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 29 APR 2026 LOT 2010228: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15-JAN-2021. EXPIRATION DATE: 2026-JAN-06. 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. 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

    AT 4 YEARS 10 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO TIBIA TRAY LOOSENING AND SUBSIDENCE. THE FEMORAL COMPONENT HAS TOO MUCH FLEXION. THE SURGEON IMPLANTED A COMPETITOR`S SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    229106 GMK PRIMARY TOTAL KNEE SYSTEM TIBIAL TRAY FIX CEMENTED S.2L JWH MEDACTA INTERNATIONAL SA 02.07.1202L 2010228 07630030819865

    Patients

    Seq Age Sex Outcome Treatment
    1