BEUDAMED
    FDA Adverse Event Death Summary report: N

    PALACOS BONE CEMENT

    MDR report key: 438673 · Received January 17, 2003

    Report

    Report Number
    1825034-2003-00024
    Event Type
    Death
    Date Received
    January 17, 2003
    Date of Event
    November 2, 2002
    Report Date
    December 18, 2002
    Manufacturer
    BIOMET, INC.
    Product Code
    LOD
    Removal / Correction Number
    NA
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    DURING PROCEDURE IN 2002, TO IMPLANT HIP PROSTHESIS, B.P. AND EKG CHANGES WERE NOTED AFTER INJECTION OF BONE CEMENT. RESUSCITATION ATTEMPTS WERE UNSUCCESSFUL. SURGEON STATES THAT THEY DID NOT THINK BONE CEMENT WAS THE CAUSE OF THE CARDIAC ARREST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS BONE CEMENT BONE CEMENT LOD BIOMET, INC. NA 03340

    Patients

    Seq Age Sex Outcome Treatment
    1 Death