BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY, INC.

    MDR report key: 185537 · Received August 31, 1998

    Report

    Report Number
    185537
    Event Type
    Injury
    Date Received
    August 31, 1998
    Date of Event
    July 21, 1998
    Report Date
    July 28, 1998
    Manufacturer
    *
    Product Code
    KWR
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD TOTAL SHOULDER REPLACEMENT 6/28/94. WAS HAVING RIGHT SHOULDER PAIN AND TAKEN TO OR ON 7/21/98 FOR PROBABLE FAILED GLENOID COMPONENT. THERE WAS SIGNIFICANT PARTICULAR DEBRIS, SYNOVITIS AND SEVERAL LARGE LOOSE FRAGMENTS OF THE SUPERIOR ASPECT AND ONE LARGE FRAGMENT WHICH WAS LOOSE WITH ATTACHED PEG WHICH WERE REMOVED. CENTRAL PORTION AND INFERIOR PORTION WAS BEGINNING TO FRAGMENT AND LOOSEN - ALSO REMOVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY, INC. Implant GLOBAL TOTAL SHOULDER KWR * 1134-88-00 82164006
    2 DEPUY INC Implant HUMERAL BODY COMPONENT HSD * 1134-34-00 886391001

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention