BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASR UNI FEMORAL IMPL SIZE 49

    MDR report key: 1945611 · Received December 30, 2010

    Report

    Report Number
    1818910-2010-10200
    Event Type
    Injury
    Date Received
    December 30, 2010
    Report Date
    February 6, 2026
    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

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE, THE ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM PLAINTIFF'S ACETABULUM, CAUSED SEVERE PAIN, AND INHIBITED THE PATIENT'S ABILITY TO WALK. PLAINTIFF WILL THEREFORE, BE REQUIRED TO UNDERGO A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASR UNI FEMORAL IMPL SIZE 49 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2564448

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention