BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 2924748 · Received January 22, 2013

    Report

    Report Number
    1818910-2013-01142
    Event Type
    Injury
    Date Received
    January 22, 2013
    Report Date
    August 22, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, 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 ALLEGES THAT THE PATIENT SUFFERED DEBILITATING PAIN, SQUEAKING AND INCREASED METALLIC IONS IN HIS BLOODSTREAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31412 ASR UNI FEMORAL IMPL SIZE 49 TOTAL HIP IMPLANT KWA DEPUY INTERNATIONAL 2997609

    Patients

    Seq Age Sex Outcome Treatment
    1 Other