BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURON 10D 54OD X 26ID

    MDR report key: 1013866 · Received March 14, 2008

    Report

    Report Number
    1818910-2008-00649
    Event Type
    Injury
    Date Received
    March 14, 2008
    Date of Event
    February 15, 2008
    Report Date
    February 15, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDL
    PMA / PMN Number
    K900832
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 WAS REVISED TO ADDRESS POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURON 10D 54OD X 26ID 87JDL JDL DEPUY ORTHOPAEDICS, INC. NA 865480006

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention