BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR ACETABULAR CUPS 50

    MDR report key: 1983602 · Received January 31, 2011

    Report

    Report Number
    1818910-2011-01507
    Event Type
    Injury
    Date Received
    January 31, 2011
    Report Date
    January 4, 2011
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    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 BEEN RECOMMENDED FOR REVISION SURGERY AFTER SWELLING DEVELOPED IN THE CREASE BETWEEN HER LEFT UPPER THIGH AND PELVIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR ACETABULAR CUPS 50 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2526287

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Required Intervention