BEUDAMED
    FDA Adverse Event Death Summary report: N

    DEPUY 1 BONE CEMENT

    MDR report key: 553799 · Received November 1, 2004

    Report

    Report Number
    553799
    Event Type
    Death
    Date Received
    November 1, 2004
    Date of Event
    October 12, 2004
    Report Date
    October 19, 2004
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LOD
    Adverse Event
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ADMITTED WITH LEFT FEMORAL NECK FRACTURE FOLLOWING FALL AT HOME. LEFT HIP BIPOLAR PROSTHESIS BEING DONE IN OPERATING ROOM AND BONE CEMENT WAS APPLIED. AFTER CEMENT HARDENED AND STEM WAS POSITIONED, THE PT DEVELOPED A BRADY ARRHYTHMIA AND A DROP IN OXYGEN SATURATION. CPR AND MEDICATION UNSUCCESSFUL IN RESUSCITATION AND PT EXPIRED. MASSIVE HEART ATTACK WAS BELIEVED TO BE CAUSE OF DEATH. UNABLE TO DETERMINE THE RELATIONSHIP OF BONE CEMENT TO OUTCOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DEPUY 1 BONE CEMENT BONE CEMENT LOD DEPUY ORTHOPAEDICS, INC. * E204G40

    Patients

    Seq Age Sex Outcome Treatment
    1 94 YR Death