BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SILASTIC WRIST JOINT IMPLANT

    MDR report key: 16295 · Received September 21, 1994

    Report

    Report Number
    MW1003461
    Event Type
    Malfunction
    Date Received
    September 21, 1994
    Date of Event
    March 1, 1994
    Report Date
    August 6, 1994
    Manufacturer
    DOW CORNING CORP.
    Product Code
    KWM
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAS LIMITED PHYSICAL ACTIVITIES DUE TO SEVERE RHEUMATOID ARTHRITIS. FRACTURE OCCURRED DURING NORMAL DAILY ACTIVITY. SURGERY REPLACEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILASTIC WRIST JOINT IMPLANT Implant SILASTIC WRIST JOINT IMPLANT KWM DOW CORNING CORP. HP100 H.H.

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR