BEUDAMED
    FDA Adverse Event Death Summary report: N

    FEMORAL NAIL 11MM X 32CM

    MDR report key: 1563957 · Received December 17, 2009

    Report

    Report Number
    1818910-2009-07101
    Event Type
    Death
    Date Received
    December 17, 2009
    Date of Event
    November 12, 2009
    Report Date
    November 17, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    HSB
    PMA / PMN Number
    K871539
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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 DUE TO SUBTROCHANTERIC FRACTURE. DURING THE SURGERY, THE NAIL WAS STUCK IN THE FEMORAL CANAL AND WAS VERY DIFFICULT TO BE REMOVED. THE NAIL WAS FINALLY REMOVED AND 1800ML BLOOD WAS LOST DURING THE SURGERY. THE SURGERY WAS EXTENDED BY 90 MINUTES. AFTER THE SURGERY, THE PATIENT WAS IN ICU. THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FEMORAL NAIL 11MM X 32CM 87HSB HSB DEPUY ORTHOPAEDICS, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR