BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE HIP

    MDR report key: 2003248 · Received February 18, 2011

    Report

    Report Number
    MW5019500
    Event Type
    Injury
    Date Received
    February 18, 2011
    Date of Event
    December 16, 2010
    Report Date
    February 18, 2011
    Manufacturer
    DEPUY
    Product Code
    KWA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OH, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    I HAD DEPUY PINNACLE HIPS IMPLANTED IN BOTH OF MY HIPS IN 2006 AND 2007. I HAVE HAD TERRIFIC PAIN, POOR GAIT, 4 DISLOCATIONS, LOOSENING OF BOTH, PSEUDOTUMOR IN LEFT LEG, AND 7 SURGERIES SINCE 2006. MY MUSCLES AND TENDONS WILL NOT STAY ATTACHED TO THE BONE DUE TO PERMANENT DAMAGE TO TISSUE AND BONE. I AM A TEACHER BUT HAVE HAD TO LEAVE MY JOB AND APPLY FOR PERMANENT DISABILITY DUE TO PAIN AND INABILITY TO WALK. I AM NOW IN A WHEELCHAIR. MY 7TH SURGERY WILL BE (B)(6) TO CORRECT PROBLEMS FROM FAILED HIP THAT DISLOCATED FOR THE FOURTH TIME ON (B)(6). MOST OF THE METAL HAS BEEN REMOVED FROM MY HIPS BUT THE DAMAGE IS BEYOND WHAT ONE CAN IMAGINE. I WILL NEVER WALK RIGHT AGAIN. THE BEST I CAN HOPE FOR IS TO USE DOUBLE CANES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE HIP TOTAL HIP REPLACEMENT KWA DEPUY

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R