BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR ADAPTER SLEEVE

    MDR report key: 2862869 · Received December 10, 2012

    Report

    Report Number
    1818910-2012-25924
    Event Type
    Injury
    Date Received
    December 10, 2012
    Report Date
    August 24, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION ALLEGED THE PATIENT SUFFERED PAIN, DISCOMFORT, METALLOSIS, PSEUDOTUMORS, DAMAGE TO SURROUNDING BONE AND TISSUE, STIFFNESS, INFLAMMATION, INFECTION, CHROMIUM AND COBALT TOXICITY AND DECREASED MOBILITY AS A RESULT OF THE IMPLANTED ASR HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR ADAPTER SLEEVE ADAPTER SLEEVE HIP IMPLANT KWA DEPUY INTERNATIONAL NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention