BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 22084266 · Received May 26, 2025

    Report

    Report Number
    3005180920-2025-00488
    Event Type
    Injury
    Date Received
    May 26, 2025
    Date of Event
    May 7, 2025
    Report Date
    May 26, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    UDI-DI
    07630030819919
    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 12-MAY-2025. LOT 172921: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-SEP-2017. EXPIRATION DATE: 07-SEP-2022. 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. 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 ABOUT 5 YEARS AND 5 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE TIBIAL TRAY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED ALL COMPONENTS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    714429 GMK PRIMARY TOTAL KNEE SYSTEM FIXED TIBIAL TRAY CEMENTED RIGHT, SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.07.1204R 172921 07630030819919

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention