BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 43315 · Received September 4, 1996

    Report

    Report Number
    43315
    Event Type
    Injury
    Date Received
    September 4, 1996
    Date of Event
    July 15, 1996
    Report Date
    August 16, 1996
    Manufacturer
    BIOMET, INC.
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    CO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    HIP PROSTHESIS HAD POLYETHYLENE WEAR WITH PERIACETABULAR OSTEOLYSIS NECESSITATING REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET Implant HIP COMPONENTS JDI BIOMET, INC. * 441170, 323930

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention