BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE METAL INSERT

    MDR report key: 4045005 · Received August 25, 2014

    Report

    Report Number
    MW5037913
    Event Type
    Injury
    Date Received
    August 25, 2014
    Date of Event
    April 21, 2014
    Report Date
    August 23, 2014
    Manufacturer
    DE PUY
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    HAD TO HAVE REVISION HIP SURGERY TO REPLACE DEPUY PINNACLE METAL INSERT AFTER 3 YEARS. DEVELOPED PAIN IN LEG/HIP AND INCREASED METAL IN BLOOD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    510984 PINNACLE METAL INSERT HIP REPLACEMENT KWA DE PUY 1218-87-352 2964658

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention