BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL SIMPLEX P

    MDR report key: 935149 · Received October 3, 2007

    Report

    Report Number
    935149
    Event Type
    Death
    Date Received
    October 3, 2007
    Date of Event
    July 24, 2007
    Report Date
    October 3, 2007
    Manufacturer
    STRYKER HOWMEDICA OSTEONICS, INC.
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    ME, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT HAD HYPOTENSIVE EPISODE IN OR DURING FIXATION OF FEMUR FRACTURE WITH SURGICAL SIMPLEX RADIOPAQUE BONE CEMENT. CHEST COMPRESSION AND PRESSORS GIVEN TO THE PATIENT. PATIENT HAD ANOTHER HYPOTENSIVE EPISODE WITH BRADYCARDIA AFTER TRANSFERRED TO ICU FROM RECOVERY AND EXPIRED. SURGEON FELT PATIENT HAD REACTION TO BONE CEMENT, WHICH IS KNOWN TO CAUSE HYPOTENSION 10 TO 165 SECONDS FOLLOWING APPLICATION. PATIENT HAD KNOWN HISTORY OF CORONARY ARTERY DISEASE AND CONGESTIVE HEART FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SIMPLEX P BONE CEMENT LOD STRYKER HOWMEDICA OSTEONICS, INC. * ME0021, ME0222

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H| R CARDIAC DRUGS