BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1864439 · Received October 6, 2010

    Report

    Report Number
    1818910-2010-07470
    Event Type
    Injury
    Date Received
    October 6, 2010
    Report Date
    October 1, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD
    Product Code
    KWY
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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 THAT THE PATIENT MAY UNDERGO REVISION SURGERY IN THE FUTURE IF INDICATED BY HIS DOCTOR FOR DISCOMFORT, HIP PAIN AND LOOSENING.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention