BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY ASR CUP

    MDR report key: 2033814 · Received March 17, 2011

    Report

    Report Number
    1818910-2011-04306
    Event Type
    Injury
    Date Received
    March 17, 2011
    Date of Event
    February 3, 2011
    Report Date
    February 15, 2011
    Manufacturer
    DEPUY INT'L., LTD.
    Product Code
    KWA
    PMA / PMN Number
    NA
    Removal / Correction Number
    Z-1749/1816-2011
    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 ACETABULAR CUP EVENTUALLY DETACHED, DISCONNECTED, CREATED METALLIC DEBRIS, AND/OR LOOSENED FROM THE PT'S ACETABULUM, CAUSED SEVERE PAIN, INHIBITED PT'S ABILITY TO WALK, AND REQUIRED A REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY ASR CUP 87KWA KWA DEPUY INT'L., LTD. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention