BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 50OD X 28ID

    MDR report key: 1222488 · Received November 5, 2008

    Report

    Report Number
    1818910-2008-05039
    Event Type
    Injury
    Date Received
    November 5, 2008
    Report Date
    October 6, 2008
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    HRY
    PMA / PMN Number
    K944538
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    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

    STRONG CRANIAL POLYETHYLENE WEAR OF INLAY AFTER SEVEN YEARS. INITIAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 50OD X 28ID 87HRY HRY DEPUY INTERNATIONAL, LTD. NA XRK-30

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention