BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 3770885 · Received April 2, 2014

    Report

    Report Number
    3770885
    Event Type
    Injury
    Date Received
    April 2, 2014
    Date of Event
    March 27, 2014
    Report Date
    April 1, 2014
    Manufacturer
    BIOMET
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT HAD RIGHT TOTAL HIP ARTHROPLASTY (THA) IN 2005. HAS HAD RIGHT HIP PAIN FOR ABOUT THE LAST YEAR OR TWO. PT HAS METAL ON METAL ARTICULATION AND REQUIRED A RIGHT THA REVISION OF ACETABULAR COMPONENT AND FEMORAL HEAD. DEVICES THAT WERE EXPLANTED WERE BIOMET MAGNUM ACETABULAR COMPONENT SIZE 52 MM AND BIOMET MAGNUM FEMORAL HEAD, METAL ON METAL ARTICULATION SIZE 46 MM. UPON REQUEST OF PT, THE EXPLANTED COMPONENTS WERE SENT TO THE PT'S ATTORNEY AND ARE NO LONGER AVAILABLE TO THE FACILITY. BIOMET REPRESENTATIVE MARK BUBLICK HAS RECEIVED A COPY OF THIS REPORT ON BEHALF OF BIOMET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    199732 BIOMET ACETABULAR CUP & FEMORAL HEAD KWA BIOMET

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention