BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ENCORE (FUTURTEK)

    MDR report key: 184364 · Received August 21, 1998

    Report

    Report Number
    MW1014480
    Event Type
    Malfunction
    Date Received
    August 21, 1998
    Date of Event
    August 17, 1998
    Manufacturer
    ENCORE ORTHOPEDICS; INC.
    Product Code
    KWY
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    OK, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    STERILIZE INDICATOR ON INSIDE PACKAGE FOR FEMORAL COMPONENT NOT CHANGED TO INDICATE STERILITY. FEMORAL PROSTHESIS (COMPONENT) WAS USED WITH OKAY FROM CO REP AND SURGEON WAS COMFORTABLE WITH THIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ENCORE (FUTURTEK) Implant FEMORAL COMPONENT (PROSTHESIS) NONPOROUS KWY ENCORE ORTHOPEDICS; INC. * 367501

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR