BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WRIST IMPLANT

    MDR report key: 53118 · Received July 31, 1996

    Report

    Report Number
    53118
    Event Type
    Injury
    Date Received
    July 31, 1996
    Report Date
    January 25, 1996
    Manufacturer
    DOW CORNING CORP.
    Product Code
    KWM
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    FAILED RIGHT WRIST IMPLANT WITH FRACTURE OF SILASTIC IMPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WRIST IMPLANT Implant SWANSON WRIST JOINT IMPLANT GROMMET 3 WP, 3WD KWM DOW CORNING CORP. * HH096295 04821686

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention