BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 2987077 · Received March 4, 2013

    Report

    Report Number
    0002249697-2013-00858
    Event Type
    Death
    Date Received
    March 4, 2013
    Date of Event
    February 15, 2013
    Report Date
    February 15, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    NURSE

    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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    NO DEVICE OR LOT INFORMATION WAS PROVIDED. THE EVENT COULD NOT BE CONFIRMED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE FURTHER INFORMATION SUCH AS THE PRIMARY OPERATIVE REPORT AS WELL AS PATIENT HISTORY AND FOLLOW-UP NOTES ARE NEEDED TO COMPLETE THE INVESTIGATION FOR DETERMINING ROOT CAUSE. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF ADDITIONAL INFORMATION BECOME AVAILABLE, THIS INVESTIGATION WILL BE REOPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SHOWED A REDUCTION IN BLOOD PRESSURE DURING USING CEMENT. SO THE SURGEON PERFORMED CARDIOPULMONARY RESUSCITATION

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT SHOWED A REDUCTION IN BLOOD PRESSURE DURING USING CEMENT. SO, THE SURGEON PERFORMED CARDIOPULMONARY RESUSCITATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    91075 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 Death