BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HEAD

    MDR report key: 1911595 · Received November 29, 2010

    Report

    Report Number
    1818910-2010-09123
    Event Type
    Injury
    Date Received
    November 29, 2010
    Date of Event
    November 12, 2014
    Report Date
    February 17, 2015
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KXA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN
    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 PAPERS ALLEGE THE PT WILL BE REVISED TO ADDRESS HIP PAIN. IT IS FURTHER ALLEGED THAT THE ASR HIP IMPLANTS ARE RELEASING METAL IONS INTO HIS BODY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HEAD TOTAL HIP REPLACEMENT KXA DEPUY INTERNATIONAL, LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention