BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANCE

    MDR report key: 189506 · Received September 29, 1998

    Report

    Report Number
    MW1014647
    Event Type
    Death
    Date Received
    September 29, 1998
    Date of Event
    August 28, 1998
    Report Date
    September 3, 1998
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    NE, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT ENDOPROSTHESIS OF HIP WITH REMOVAL OF TUMOR-TISSUE AND FIXATION WITH METHYL METHACRYLATE CEMENT. A SECOND OPERATION INTERMEDULLARY NAILING FOR PATHOLOGIC FRACTURE OF THE HUMEROUS. METHYL METHACRYLATE CEMENT WAS MIXED AND PLACED IN THE CANAL AND AN INTERMEDULLARY NAIL WAS THEN TAPPED THROUGH THE WET CEMENT INTO THE HUMEROUS. APPROX AT THE TIME THE INTERMEDULLARY NAIL WAS INSERTED, OR PERHAPS A LITTLE AFTER THIS, THE PT'S VITAL SIGNS DROPPED, HER BLOOD PRESSURE DROPPED AND SHE BECAME UNRESPONSIVE. CARDIOPULMONARY RESUSCITATION WAS UNSUCCESSFUL AND PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANCE Implant BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. 40G 80G 40G X162J40

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death BIOSTOP G CEMENT RESTRICTOR SIZE 12MM.