BEUDAMED
    FDA Adverse Event Death Summary report: N

    ENDURANCE MV

    MDR report key: 901181 · Received August 16, 2007

    Report

    Report Number
    901181
    Event Type
    Death
    Date Received
    August 16, 2007
    Date of Event
    August 1, 2007
    Report Date
    August 16, 2007
    Manufacturer
    DEPUY ORTHOPAEDICS, INC
    Product Code
    LOD
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    PATIENT SCHEDULED FOR HIP REPLACEMENT SURGERY FOR DISPLACED RIGHT HIP FEMORAL NECK FRACTURE WITH DIFFUSE OSTEOPENIA. PATIENT PREPPED FOR SURGERY WITH SPINAL BLOCK ANESTHESIA. EVENT CHRONOLOGY: AT 19:45, PROCEDURE STARTED. AT 20:12 FEMORAL HEAD EXCISED AND CEMENT APPLIED. AT 20:15, O2 SATURATION, BLOOD PRESSURE AND PULSE DROPPED SIGNIFICANTLY. TREATED WITH MEDICATIONS AND LARYNGEAL MASK AIRWAY. AT 20:28, PROCEDURE COMPLETED, PT SUPINE AND INTUBATED. RESUSCITATION CONTINUED. AT 20:49, PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENDURANCE MV BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC SMARTSET MV 2354784

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death