BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL SIMPLEX P

    MDR report key: 122715 · Received September 26, 1997

    Report

    Report Number
    122715
    Event Type
    Death
    Date Received
    September 26, 1997
    Date of Event
    June 24, 1997
    Report Date
    September 22, 1997
    Manufacturer
    HOWMEDICA INC
    Product Code
    LOD
    Report Source
    User Facility report
    Reporter Location
    MA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ON 07/29/97 A NOTICE WAS SENT FROM PFIZER HOSPITAL PRODUCTS GROUP TO HOSPITAL REQUESTING INFORMATION REGARDING AN INCIDENT INVOLVING ONE OF THEIR PRODUCTS. PT PULLED THE PATIENTS MEDICAL RECORD AND THERE WAS NO NOTATION OF ANY INCIDENT WITH THEIR PRODUCTS. PT SPOKE WITH THE ANESTHESIOLOGIST ON THE CASE WHO SAID THE PATIENT WAS EXTREMELY ILL AND THERE WAS SOME DISCUSSION OF A DIFFERENTIAL DIAGNOSIS INVOLVING THE CEMENT AND THE PATIENT'S SUBSEQUENT CARDIAC ARREST. PT WAS UNABLE TO CONTACT THE ORTHOPEDIC PHYSICIAN AS HE WAS AWAY UNTIL SEPTEMBER. WHEN PT WAS ABLE TO DISCUSS THIS CASE WITH THE ORTHOPEDIC PHYSICIAN HE CONFIRMED WHAT THE ANESTHESIOLOGIST STATED, IN THAT THERE ARE REPORTED CASES IN THE MEDICAL LITERATURE OF INSTANCES WHERE A PATIENT'S DEATH WAS ATTRIBUTABLE TO THE CEMENT. NEITHER PHYSICIAN FELT IT WAS DEFINITIVE AS THIS WAS A VERY SICK PATIENT. A CALL WAS MADE TO THE MANUFACTURER WHO FELT THAT PT SHOULD FILE A REPORT EVEN AT THIS LATE DATE AND EVEN IF IT WAS UNSURE OF THE RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND THE USE OF THE CEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SIMPLEX P RADIOPAQUE BONE CEMENT LOD HOWMEDICA INC * *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Death