BEUDAMED
    FDA Adverse Event Death Summary report: N

    M/G PRECOAT TIBIAL PLATE 46 X 67MM

    MDR report key: 77463 · Received March 13, 1997

    Report

    Report Number
    2529767-1997-00002
    Event Type
    Death
    Date Received
    March 13, 1997
    Date of Event
    November 19, 1996
    Report Date
    March 13, 1997
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSH
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    PT HAD A RIGHT TOTAL KNEE REPLACEMENT IN 2/90. PT HAD INSIDIOUS ONSET OF PAIN IN THE PROXIMAL RIGHT TIBIA. X-RAYS SHOWED THE PROSTHESIS HAD LOOSENED AND SHIFTED. SHE WAS ADMITTED FOR REVISION OF TOTAL KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M/G PRECOAT TIBIAL PLATE 46 X 67MM Implant TIBIAL PLATE HSH ZIMMER, INC. NA 68205900

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention 2. 5784-010 LOT # 66136100 (NOT RETURNED)| 1. 5220-012 LOT # 68916400 (NOT RETURNED)| 3. 5780-042-16 LOT #63987000