BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ASR HEAD

    MDR report key: 1222463 · Received November 4, 2008

    Report

    Report Number
    1818910-2008-04717
    Event Type
    Injury
    Date Received
    November 4, 2008
    Date of Event
    September 3, 2014
    Report Date
    September 3, 2014
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWY
    Removal / Correction Number
    Z-1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER
    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

    REVISION DUE TO PAIN. REVISED 6 MONTHS AFTER BEING IMPLANTED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Female Required Intervention