BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TAPERLOC POR FMRL LAT 13.5X147

    MDR report key: 2830313 · Received November 6, 2012

    Report

    Report Number
    MW5027562
    Event Type
    Injury
    Date Received
    November 6, 2012
    Date of Event
    April 12, 2012
    Report Date
    November 6, 2012
    Manufacturer
    BIOMET
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I REC'D A TOTAL HIP REPLACEMENT ON (B)(6) 2006, AT (B)(6) HOSPITAL DONE BY DR (B)(6). I REC'D A BIOMET TAPERLOC FEMORAL HEAD ALONG WITH A BIOMET ARCOM 28MM RINGLOC JOINT. I WAS NEVER HAPPY AND I MADE THE DOCTOR AWARE OF MY DIFFICULTIES. I HAVE HAD INCREASED PAIN AND REMAINED IN VARIOUS PAIN MANAGEMENTS THROUGH THE YRS. IN 2010, THE PAIN INCREASED EXPONENTIALLY, AND I DEVELOPED PERIPHERAL NEUROPATHY. IN (B)(6) 2012, THE PAIN HAD REACHED A POINT I COULD NO LONGER FUNCTION AND I BECAME UNEMPLOYED. THE VA HAS BEEN TREATING MY SYMPTOMS, BUT IT HAS GOTTEN TO THE POINT THAT I CAN HARDLY WALK. MY QUALITY OF LIFE HAS DECREASED TO THE POINT I CAN HARDLY FUNCTION, IN DAILY ACTIVITIES. I HAVE BEEN WAITING FOR A ADVISORY OR RECALL ON THIS DEVICE, AS OTHERS HAVE. I HAVE NO HEALTH INSURANCE SINCE I AM UNABLE TO WORK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET TAPERLOC POR FMRL LAT 13.5X147 HIP REPLACEMENT COMPONENTS KWA BIOMET 534210
    2 BIOMET ARCOM 28MM RNGLOC HWALL 25 HIP REPLACEMENT COMPONENTS KWA BIOMET 572570

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Disability