BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P RADIOPAQUE UNIT

    MDR report key: 209825 · Received February 10, 1999

    Report

    Report Number
    9610726-1999-00008
    Event Type
    Death
    Date Received
    February 10, 1999
    Date of Event
    December 29, 1998
    Report Date
    February 9, 1999
    Manufacturer
    HOWMEDICA INC.
    Product Code
    LOD
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    RPTR STATED, "THE PT HAD AN OLD FEMORAL NECK FRACTURE AND SEVERE OSTEOPOROSIS. THE SURGEON CHOSE TO IMPLANT A HOWMEDICA EMERALD LONG STEM AND VITALOCK CUP. THE PT ALSO HAD HEART DISEASE WHICH WAS UNDER MEDICAL CONTROL. CEMENT WAS INJECTED AND APPROX TWO MINS LATER, THE BLOOD PRESSURE OF THE PT DROPPED TO ZERO. THE PT DIED IN THEATRE AFTER 1 HR."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P RADIOPAQUE UNIT Implant OTHER LOD HOWMEDICA INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Death