BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 278849 · Received May 22, 2000

    Report

    Report Number
    MW1018953
    Event Type
    Malfunction
    Date Received
    May 22, 2000
    Date of Event
    April 20, 2000
    Report Date
    May 3, 2000
    Manufacturer
    BIOMET, INC.
    Product Code
    KWB
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BIOMET HIP LOCKING RING AND LINER REMOVED FROM THE PT'S LEFT HIP BECAUSE THE RING WAS BROKEN. LINER WAS ALSO BROKEN AS NOTED UPON ENTRY INTO THE HIP JOINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET RING-LOC 32MM CONSTRAINED 10 DEGREE KWB BIOMET, INC. 9604 787921
    2 BIOMET 1 PIECE LINER SIZE 13 WITH CONSTRAINED RING KWB BIOMET, INC. NI NI

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR Other