BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 5461503 · Received February 25, 2016

    Report

    Report Number
    0002249697-2016-00583
    Event Type
    Death
    Date Received
    February 25, 2016
    Date of Event
    January 15, 2016
    Report Date
    February 1, 2016
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE REMAINED IMPLANTED IN THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE IT WILL BE REPORTED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    ON (B)(6) 2016, THE PATIENT HAS DIED DURING CEMENTED BIPOLAR SURGERY. THE USED IMPLANTS ARE OTHER COMPANY PRODUCTS. THE TEMPERATURE OF THE OPERATION ROOM WAS 21' THE CEMENT STORAGE TEMPERATURE WAS 6', THE CEMENT GUN WAS USED, THE PULS IRRIGATION OF MEDULLARY CAVITY WAS DONE. THE CEMENT WAS TAKEN OUT FROM THE STORAGE JUST BEFORE USE. THE STIRRING WAS PERFORMED 1 MINUTE. THEN IT WAS LEFT TO STAND FOR 1 MINUTE BEFORE INSERTION. THE PATIENTS' BLOOD PRESSURE BEGAN TO DECLINE JUST AFTER CEMENT INSERTION. ALTHOUGH THE PRESSOR AGENT WAS USED, THE PATIENT HAS DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    117827 SIMPLEX P-JAPANESE TWIN PACK BONE CEMENT LOD STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 99 YR Death