BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 46

    MDR report key: 2250889 · Received September 16, 2011

    Report

    Report Number
    1818910-2011-18337
    Event Type
    Injury
    Date Received
    September 16, 2011
    Report Date
    February 27, 2026
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    K040627
    Removal / Correction Number
    Z1749/1816-2011
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY
    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

    LITIGATION PAPERS ALLEGE: ON (B)(6) 2008, PATIENT WAS IMPLANTED WITH A DEPUY ASR HIP ON HER RIGHT SIDE. SHE HAS SUFFERED PAIN, SWELLING, INFLAMMATION, AND DAMAGE TO THE BONE AND TISSUE SURROUNDING THE IMPLANT. SHE MAY REQUIRE REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 46 HIP KWA DEPUY INTERNATIONAL 2549256

    Patients

    Seq Age Sex Outcome Treatment
    1