BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLOBAL TOTAL SHOULDER

    MDR report key: 117504 · Received August 27, 1997

    Report

    Report Number
    MW1012023
    Event Type
    Injury
    Date Received
    August 27, 1997
    Date of Event
    November 1, 1993
    Report Date
    August 27, 1997
    Manufacturer
    DEPUY, INC.
    Product Code
    KWS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    IN 1993 RPTR HAD A LEFT TOTAL SHOULDER REPLACEMENT, FOR 2 YRS SHOULDER WAS WORKING WELL. THEN RPTR DEVELOPED INCREASING PAIN AND AT TIMES SHOULDER WOULD LOCK. DR OPERATED ON SHOULDER 8/7/96 AND FOUND THE PLASTIC ROTOR CUP HAD BROKEN INTO LITTLE PIECES, THE CUP WAS MADE BY DEPUY # ON THE PLASTIC IS 00-1134-96. RPTR NOW HAS ALL OF THE REPLACEMENTS REMOVED. RPTR HAS VERY LITTLE USE OF LEFT ARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 GLOBAL TOTAL SHOULDER Implant FINNED GLENDID KWS DEPUY, INC. * 824580044
    2 GLOBAL TOTAL SHOULDER Implant HUMERAL BODY COMPONENT KWS DEPUY, INC. * 602680001
    3 GLOBAL TOTAL SHOULDER Implant HUMERAL HEAD KWS DEPUY, INC. * 606130002

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Hospitalization| R| S