BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK DEPUY ASR HIP

    MDR report key: 1962426 · Received January 7, 2011

    Report

    Report Number
    1818910-2011-00366
    Event Type
    Injury
    Date Received
    January 7, 2011
    Date of Event
    December 6, 2010
    Report Date
    December 10, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    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 HAS SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PAIN, POPPING AND CLICKING FROM HIS HIPS WHILE WALKING, TENDERNESS AND LOOSENING. BILATERAL THA DOI: (B)(6) 2007; RIGHT REVISION DOR: (B)(6) 2010.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 41 YR Required Intervention