BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 518129 · Received March 12, 2004

    Report

    Report Number
    518129
    Event Type
    Injury
    Date Received
    March 12, 2004
    Date of Event
    January 13, 2004
    Report Date
    February 26, 2004
    Manufacturer
    BIOMET
    Product Code
    KWY
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OK, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THIS PT HAS AN INFECTED RIGHT TOTAL HIP ARTHOPLASTY. PT HAS HAD NUMEROUS DISLOCATIONS. THE PT WAS ADMITTED FOR REVISION TOTAL HIP ARTHROPLASTY. ALL COMPONENTS WERE REMOVED AND REPLACED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET TOTAL HIP COMPONENTS/BI-METRIC FEMORAL POROUS COATED KWY BIOMET * 516410
    2 BIOMET OSTEONICS OMNIFIT 10 DEGREE CUP INSERT - SERIES II JDI BIOMET, INC. * 89236501

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R