BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON NEUT 54OD X 28ID

    MDR report key: 1931356 · Received December 15, 2010

    Report

    Report Number
    1818910-2010-09786
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    November 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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

    PATIENT REVISED FOR OSTEOLYSIS AND POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON NEUT 54OD X 28ID 87HRY LPH DEPUY ORTHOPAEDICS, INC. NA SJ4DR1017

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention