BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET

    MDR report key: 3092158 · Received April 29, 2013

    Report

    Report Number
    MW5030015
    Event Type
    Injury
    Date Received
    April 29, 2013
    Date of Event
    August 25, 2008
    Report Date
    April 29, 2013
    Manufacturer
    BIOMET
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NM, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    ARTHROPROSTHETIC COBALTISM AND FAILED HIP ARTHROPLASTY, COGNITIVE DECLINE, MENTAL CONFUSION, MEMORY DECLINE, EXTREME ANXIETY, PROFOUND FATIGUE, TINNITUS, NEUROPATHY, HIP PAIN WITH GRINDING, POPPING SQUEAKING NOISES, HYPOTHYROIDISM, TACHYCARDIA (B)(6) 2008, TOTAL HIP ARTHROPLASTY (B)(6) 2011, 1ST HIP REVISION (B)(6) 2011, 1ST ANTERIOR DISLOCATION (B)(6) 2011, 2ND ANTERIOR DISLOCATION WITH TROCHANTER FRACTURE (B)(6) 2011, 2ND HIP REVISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    184331 BIOMET BIOMET M2A MAGNUM 48MM KWA BIOMET M2A MAGNUM 48MM 545090

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Other| R| S