BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL SIMPLEX P

    MDR report key: 315632 · Received February 7, 2001

    Report

    Report Number
    315632
    Event Type
    Death
    Date Received
    February 7, 2001
    Date of Event
    February 2, 2001
    Report Date
    February 7, 2001
    Manufacturer
    HOWMEDICA INTERNATIONAL S. DE R.L.
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT IN OPERATING ROOM FOR INSERTION OF BIPOLAR PROSTHESIS WITH BONE CEMENT FOLLOWING FRACTURE OF HIP. IMMEDIATELY AFTER THE CEMENT WAS INJECTED PT DEVELOPED SEVERE HYPOTENSION AND WENT INTO CARDIAC ARREST. RESUSCITATIVE ATTEMPTS WERE UNSUCCESSFUL AND PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    4584 SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT LOD HOWMEDICA INTERNATIONAL S. DE R.L. * RIH370

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Death