BEUDAMED
    FDA Adverse Event Death Summary report: N

    M/DN INTRAMEDULLARY FIXATION FEMORAL/RECON NAIL

    MDR report key: 438258 · Received January 17, 2003

    Report

    Report Number
    1822565-2003-00007
    Event Type
    Death
    Date Received
    January 17, 2003
    Date of Event
    December 3, 2002
    Report Date
    December 18, 2002
    Manufacturer
    ZIMMER, INC.
    Product Code
    HSB
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THAT FOLLOWING A TRAFFIC ACCIDENT, WHICH FRACTURED THE LEFT FEMORAL, THE PATIENT HAD A FEMORAL NAILING. THE FOLLOWING DAY THE FEMORAL NAIL HAD TO BE REMOVED TO AMPUTATE THE LEFT LEG. THE SCREWS WERE DIFFICULT TO REMOVE AND CAUSED A 40 MINUTE DELAY TO THE PROCEDURE. THE PATIENT DIED LATER THAT DAY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 M/DN INTRAMEDULLARY FIXATION FEMORAL/RECON NAIL IM ROD HSB ZIMMER, INC. NA 23666400

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| H| R