BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK HINGE TOTAL KNEE SYSTEM

    MDR report key: 20620260 · Received November 6, 2024

    Report

    Report Number
    3005180920-2024-00878
    Event Type
    Injury
    Date Received
    November 6, 2024
    Date of Event
    October 7, 2024
    Report Date
    November 6, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    KRO
    UDI-DI
    07630030825606
    PMA / PMN Number
    K130299
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 OCTOBER 2024: LOT 2001373: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUN-2020. EXPIRATION DATE: 2025-06-14. 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. ROOT CAUSE: 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

    3 YEAR AND 2 MONTHS FROM PRIMARY SURGERY THE PATIENT HAD PAIN DUE TO A LOOSE TIBIA AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE INSERT AND TIBIA; THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2132123 GMK HINGE TOTAL KNEE SYSTEM GMK-HINGE FIXED TIBIAL TRAY SIZE 5 KRO MEDACTA INTERNATIONAL SA 02.09.4005R 2001373 07630030825606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention