BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 2034064 · Received March 24, 2011

    Report

    Report Number
    1818910-2011-04870
    Event Type
    Injury
    Date Received
    March 24, 2011
    Report Date
    February 21, 2011
    Manufacturer
    DEPUY INTL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    ATTORNEY
    Health Professional
    N

    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 BASED ON THE ELEVATED LEVELS OF COBALT AND CHROMIUM IN PT'S BODY, PT WILL LIKELY BE REQUIRED TO UNDERGO REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP NONE KWA DEPUY INTL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention