BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GMK TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT

    MDR report key: 3121761 · Received May 8, 2013

    Report

    Report Number
    3006639916-2013-00052
    Event Type
    Injury
    Date Received
    May 8, 2013
    Date of Event
    April 12, 2013
    Report Date
    May 8, 2013
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    SZ
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Description of Event or Problem · 1

    REVISION SURGERY 3 MONTHS POST OP. DUE TO SUBSIDENCE OF THE TIBIAL TRAY. REF # 3005180920-2013-00052.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202370 GMK TIBIAL TRAY FIXED CEMENTED SIZE 4 RIGHT KNEE TIBIAL COMPONENT JWH MEDACTA INTERNATIONAL SA 122303

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention