BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY PINNACLE

    MDR report key: 2140541 · Received June 21, 2011

    Report

    Report Number
    MW5021112
    Event Type
    Injury
    Date Received
    June 21, 2011
    Date of Event
    May 7, 2008
    Report Date
    June 21, 2011
    Manufacturer
    DEPUY
    Product Code
    KWA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    LA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    LOOSENING OF THE ACETABULAR CUP WITH THE DEPUY PINNACLE SYSTEM. I HAVE EXTREME PAIN IN THE LEFT HIP, THIGH, AND GROIN AREA. I AM UNABLE TO APPLY WEIGHT TO LEFT LEG AND HAVE LIMITED MOBILITY. I WAS INFORMED THAT I WILL NEED A SECOND OPERATION TO REMOVE THE IMPLANT. REASON FOR USE: NECROSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY PINNACLE HIP SYSTEM KWA DEPUY A4XF81000

    Patients

    Seq Age Sex Outcome Treatment
    1 37 YR Hospitalization| R| S