BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK PRIMARY TOTAL KNEE SYSTEM

    MDR report key: 21476354 · Received February 27, 2025

    Report

    Report Number
    3005180920-2025-00098
    Event Type
    Injury
    Date Received
    February 27, 2025
    Date of Event
    January 31, 2025
    Report Date
    February 27, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    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 04-02-2025: LOT 161370: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-05-2016. EXPIRATION DATE: 2021-05-12. 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. 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

    REVISION SURGERY AT 8 YEARS AND 4 MONTHS DUE TO A DEPRESSION OF THE TIBIAL PLATEAU LINKED TO PATIENT'S WEIGHT. TIBIAL TRAY AND INSERT WERE REVISED, GMK-REVISION TIBIAL TRAY WITH WEDGES AND EXTENSION STEM IMPLANTED. NO TRAUMA, NO LOOSENING OF THE FEMORAL COMPONENT AND NO INFECTION WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698214 GMK PRIMARY TOTAL KNEE SYSTEM KNEE TIBIAL TRAY CEMENTED SIZE 4 JWH MEDACTA INTERNATIONAL SA 02.07.1204L 153509

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Required Intervention