BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 1951103 · Received December 29, 2010

    Report

    Report Number
    MW5018839
    Event Type
    Injury
    Date Received
    December 29, 2010
    Date of Event
    June 17, 2007
    Report Date
    December 29, 2010
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    TX, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD A TOTAL HIP REPLACEMENT THREE YEARS AGO AND HAVE EXPERIENCED NUMEROUS COMPLICATIONS SINCE: ATROPHY, NERVE DAMAGE, CHRONIC PAIN AND MOST RECENTLY UNUSUAL BLOOD WORK UP RESULTS. MY IMPLANT IS A BIOMET METAL-ON-METAL, M2A MAGNUM. I AM IN CHRONIC PAIN WHICH IS ONLY GETTING WORSE. DATES OF USE: (B)(6) 2007 - (B)(6) 2010. DIAGNOSIS OR REASON FOR USE: AVN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET M2A MAGNUM METAL ON METAL HIP 38MM HEAD KWA M2A MAGNUM 833660
    2 BIOMET M2A MAGNUM METAL ON METAL HIP 38MM HEAD KWA M2A MAGNUM 072810
    3 BIOMET M2A MAGNUM METAL ON METAL HIP 38MM HEAD KWA M2A MAGNUM

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention