BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET INC

    MDR report key: 225402 · Received May 26, 1999

    Report

    Report Number
    MW1016403
    Event Type
    Injury
    Date Received
    May 26, 1999
    Date of Event
    March 9, 1999
    Report Date
    May 20, 1999
    Manufacturer
    BIOMET INC
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    CERAMIC HEAD OF TOTAL HIP PROSTHESIS BROKE INTO 3 PIECES, REQUIRING SURGERY TO REPLACE IT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET INC Implant MODULAR ACETABULAR HEAD KWY BIOMET INC 28 MM MINUS 5 HEAD 976480

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention