BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ASR FEM IMPLANT SZ 46

    MDR report key: 1905521 · Received November 19, 2010

    Report

    Report Number
    1818910-2010-08538
    Event Type
    Injury
    Date Received
    November 19, 2010
    Date of Event
    October 20, 2010
    Report Date
    October 20, 2010
    Manufacturer
    DEPUY INT'L
    Product Code
    KXA
    PMA / PMN Number
    K032659
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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

    PT WAS REVISED TO ADDRESS PAIN. WHITE/GREY FLUID AND TISSUE WAS FOUND, BUT NO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY ASR FEM IMPLANT SZ 46 87KXA KXA DEPUY INT'L NA Y38F21

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention