BEUDAMED
    FDA Adverse Event Death Summary report: N

    SURGICAL SIMPLEX P

    MDR report key: 132 · Received December 31, 1991

    Report

    Report Number
    132
    Event Type
    Death
    Date Received
    December 31, 1991
    Date of Event
    December 13, 1991
    Report Date
    December 19, 1991
    Manufacturer
    HOWMEDICA
    Product Code
    JXH
    Adverse Event
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    DURING REPAIR FRACTURED HIP, PATIENT BECAME HYPOTENSIVE AT TIME OF APPLICATION OF BONE CEMENT, METHYL METHACRYLATE. POST -OPERATIVE HEAD CAT SCAN REVEALED LARGE INFARCT CEREBELLUM. PATIENT EXPIRED THE FOLLOWING DAY. KNOW ADVERSE REACTION OF METHYL METHACRYLATE INCLUDE: CEREBROVASCULAR ACCIDENT, MYOCARDIAL INFARCTION, CARDIAC ARREST, SUDDEN DEATHDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: SATISFACTORY CONDITION. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY. NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS NOT EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NO DATA. RESULTS OF EVALUATION: NO DATA. CONCLUSION: NO DATA. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: INVALID DATA. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SURGICAL SIMPLEX P Implant METHYL METHACRYLATE JXH HOWMEDICA UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Death