BEUDAMED
    FDA Adverse Event Death Summary report: N

    SIMPLEX P BONE CEMENT

    MDR report key: 5421 · Received May 10, 1993

    Report

    Report Number
    34462-1993-00002
    Event Type
    Death
    Date Received
    May 10, 1993
    Date of Event
    February 19, 1993
    Manufacturer
    HOWMEDICA
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    PA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    AT THE TIME OF CEMENT IMPLANTATION, PATIENT EXPERIENCED RESPIRATORY ARREST AND SUBSEQUENT CARDIAC ARREST REQUIRING. PATIENT WAS SUCESSFULLY RESUSCITATED IN THE O.R. AND CODED IN THE RECOVERY ROOM EXPIRATION OCCURRED APPROX. THREE HOURS POST-OP IN RECOVERY. PRESUMED CAUSE OIF DEATH PULMONARY EMBOLUS. CEMENT WAS BEING USED WITH RICHARDS BI-POLAR HIPDEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. 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. INVALID DATA - REGARDING WHETHER EVENT PRESENTS IMMINENT HAZARD. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: NONE OR UNKNOWN. RESULTS OF EVALUATION: NONE OR UNKNOWN. CONCLUSION: NONE OR UNKNOWN. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: YES. CORRECTIVE ACTIONS: NONE OR UNKNOWN. INVALID DATA - ON DEVICE DESTROYED/DISPOSED OF STATUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIMPLEX P BONE CEMENT Implant BONE CEMENT LOD HOWMEDICA RAA 312

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Death