BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 471033 · Received July 2, 2003

    Report

    Report Number
    MW1028934
    Event Type
    Malfunction
    Date Received
    July 2, 2003
    Date of Event
    June 18, 2003
    Report Date
    June 25, 2003
    Manufacturer
    BIOMET, INC.
    Product Code
    HSH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    WEAR NOTED ON EXPLANTED TIBIAL BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET MAXIM PS TIBIAL BEARING HSH BIOMET, INC. * 027520

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Other