BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZIMMER

    MDR report key: 87191 · Received April 22, 1997

    Report

    Report Number
    33458-1997-00002
    Event Type
    Injury
    Date Received
    April 22, 1997
    Date of Event
    April 2, 1997
    Report Date
    April 9, 1997
    Manufacturer
    ZIMMER, INC.
    Product Code
    HTG
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    DEVICE SEPARATED FROM METAL BACKING ON PATELLA. ALL IMPLANT COMPONENTS WERE REPLACED. FEMORAL 5780-013, LOT #60784500. TIBIAL SURFACE: 5780-052-13, LOT #61442000. TIBIAL: 5780-070-04, LOT #5122900. PATELLA 8505-852-37, LOT #62116400. HOSP DISPOSED OF IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER Implant MILLER GELANTE POROUS PATELLAR DOME HTG ZIMMER, INC. NA 62116400

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention