BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P-JAPANESE TWIN PACK

    MDR report key: 1425165 · Received July 29, 2009

    Report

    Report Number
    9610726-2009-00152
    Event Type
    Death
    Date Received
    July 29, 2009
    Date of Event
    July 6, 2009
    Report Date
    July 7, 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
    JA
    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. AND WAS CLEARED. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED, AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, IT WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING BHA SURGERY AFTER PLACING A CEMENT PLUG INTO THE FEMORAL CANAL, THE CEMENT WAS INJECTED AND THE STEM WAS PLACED, THEN THE BLOOD PRESSURE DROPPED AND THE PT WAS TRANSFERRED TO ICU. HOWEVER, THE PT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P-JAPANESE TWIN PACK IMPLANT LOD STRYKER ORTHOPAEDICS LIMERICK NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death