BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL SIMPLEX CEMENT

    MDR report key: 1413655 · Received July 13, 2009

    Report

    Report Number
    9610726-2009-00130
    Event Type
    Death
    Date Received
    July 13, 2009
    Date of Event
    June 12, 2009
    Report Date
    June 16, 2009
    Manufacturer
    STRYKER ORTHOPAEDICS LIMERICK
    Product Code
    LOD
    PMA / PMN Number
    NA
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

    Description of Event or Problem · 1

    AT 10:25 AM IN 2009, THE PATIENT WAS HAVING A FEMORAL HEAD REPLACEMENT SURGERY, WHEN THE PATIENT WAS IMPLANTED 60G BONE CEMENT INTO HER MEDULLARY CAVITY, HER BLOOD PRESSURE DROPPED SUDDENLY, HEARTBEAT AND BREATHING STOPPED AT ONCE, IT IS CONSIDERED AS ANAPHYLACTIC SHOCK. THE OPERATION WAS IMMEDIATELY SUSPENDED, AND A CARDIOPULMONARY RESUSCITATION CARRIED OUT. INJECTED DEXAMETHASONE, EPINEPHRINE, AND APPLIED ENDOTRACHEAL INTUBATION, THE HEART OF EXTERNAL CHEST COMPRESSION, DEFIBRILLATION, NUTRITION, EMERGENCY TREATMENT MEASURES, COMPLETED THE SURGERY AFTER PATIENT CARDIO-PULMONARY FUNCTION RECOVERED. PATIENT TRANSFERRED TO MEDICAL FOR TREATMENT. AND AT 0:15 IN THE NEXT DAY, PATIENT BLOOD PRESSURE DECREASED ONCE AGAIN, CARDIAC ARREST, AFTER THE DEATH OF ALL RESCUE MEASURES PROVED INEFFECTUAL IN 00:30.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SIMPLEX CEMENT IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA CFP089

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK