BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR HIP

    MDR report key: 1945523 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10212
    Event Type
    Injury
    Date Received
    December 30, 2010
    Report Date
    December 1, 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
    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 ONE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PT SUFFERED SYMPTOMS INCLUDING, BUT NOT LIMITED TO PAIN, SWELLING, INFLAMMATION, INFECTION, AND DAMAGE TO SURROUNDING BONE AND TISSUE AND LACK OF MOBILITY AND REQUIRED REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR HIP 87KWA KWA DEPUY INTERNATIONAL, LTD. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention