BEUDAMED
    FDA Adverse Event Other Summary report: N

    PALACOS CEMENT

    MDR report key: 499520 · Received December 1, 2003

    Report

    Report Number
    499520
    Event Type
    Other
    Date Received
    December 1, 2003
    Date of Event
    October 1, 2003
    Report Date
    October 1, 2003
    Manufacturer
    BIOMET, INC.
    Product Code
    LOD
    Report Source
    User Facility report
    Reporter Location
    KY, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    A FIRE SPONTANEOUSLY COMBUSTED IN THE PT'S LEFT KNEE APPROX 5" IN HEIGHT DURING TOTAL KNEE REPLACEMENT SURGERY. THE PHYSICIAN WAS USING BIOMET PALACOS CEMENT AND RICHARDS CERAMIC IMPLANTS. THE FIRE WAS EXTINGUISHED WITH A WET LAP SPONGE. DURING THE SURGERY, A BOVIE WAS USED; HOWEVER, AT THE TIME OF THE FIRE IGNITION, THE BOVIE WAS WELL OUT OF THE REACH OF THE FIELD AND NOT BEING USED. THE SURGEON FLEXED THE KNEE TO CHECK FOR ALIGNMENT OF THE PATELLAR COMPONENT. TAPPED THE COMPONENT FOR SECURITY, EXTENDED THE KNEE, TURNED TO THE SCRUB, AND TURNED BACK TO THE FIELD, AND THE SITE WAS ON FIRE. ALL THIS HAPPENED WITHIN A SECOND OR TWO. THERE WAS NO INDICATION THAT THE PT WAS BURNED OR INJURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PALACOS CEMENT BONE CEMENT LOD BIOMET, INC. * 003392
    2 GENSIS II POSTERIOR STABILIZED OXINUM FEMORAL COMPONENT SIZE KNEE FEMORAL COMPONENTS LOD SMITH & NEPHEW ORTHOPAEDICS * 03CM04526
    3 * STEM LOD SMITH & NEPHEW ORTHOPAEDICS * 03HM07129

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other RICHARDS CERAMICS IMPLANT.