BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ENDURANCE SZ 2 HIGH OFFSET

    MDR report key: 1170003 · Received September 18, 2008

    Report

    Report Number
    1818910-2008-03998
    Event Type
    Injury
    Date Received
    September 18, 2008
    Date of Event
    August 19, 2008
    Report Date
    August 19, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JDI
    PMA / PMN Number
    K942370
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, 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

    THE PATIENT WAS REVISED BECAUSE OF A FRACTURED BONE AND THE STEM LOOSENING. IT WAS NOTED THAT THE PATIENT HAD FALLEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANCE SZ 2 HIGH OFFSET 87JDI JDI DEPUY ORTHOPAEDICS, INC. NA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention