BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOWMEDICA/OSTEONICS

    MDR report key: 1150491 · Received August 22, 2008

    Report

    Report Number
    1150491
    Event Type
    Malfunction
    Date Received
    August 22, 2008
    Date of Event
    July 30, 2008
    Report Date
    August 22, 2008
    Manufacturer
    STRYKER ORTHOPAEDICS
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MA, US

    Narratives

    Description of Event or Problem · 1

    PATIENT WAS UNDERGOING A RESECTION OF A LEFT PROXIMAL FEMUR LESION WITH EXPECTED PLACEMENT OF A LONG, CURVED STEM FROM THE STRYKER GLOBAL MODULAR REPLACEMENT SYSTEM. (THESE DEVICES ARE NOT KEPT ON HOSPITAL SHELVES, BUT ARE SHARED AMONG HOSPITALS WHEN THE NEED ARISES. THEY MUST BE ORDERED IN ADVANCE.) ONCE PATIENT'S LEG WAS PREPARED, THREE INTACT SHRINK-WRAPPED BOXES WERE OPENED. ALL THREE HAD BROKEN SEALS IN THE INTERNAL PACKAGING. TWO WERE POROUS IMPLANTS, BUT A THIRD WAS NOT SO IT WAS DECIDED TO FLASH STERILIZE THE THIRD ONE AND IMPLANT IT. PROPER STERILIZATION PROCEDURE WAS FOLLOWED AND APPROPRIATE BIOLOGICAL INDICATOR WAS UTILIZED AND WAS NEGATIVE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HOWMEDICA/OSTEONICS IMPLANT, ORTHOPEDIC, MODULAR KWY STRYKER ORTHOPAEDICS * #1: J2108TEC607B

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR NO OTHER THERAPIES| NO OTHER THERAPIES