BEUDAMED
    FDA Adverse Event Other Summary report: N

    ST GOBAIN

    MDR report key: 437552 · Received January 13, 2003

    Report

    Report Number
    MW1027213
    Event Type
    Other
    Date Received
    January 13, 2003
    Date of Event
    May 16, 2001
    Report Date
    January 13, 2003
    Manufacturer
    CERAMIQUES AVANCEES DESMARQUES
    Product Code
    JDI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    PATIENT

    Narratives

    Description of Event or Problem · 1

    CALLER DISCOVERED THE LEFT HIP IMPLANT IS BEING RECALLED. PT HAS ATTEMPTED TO CALL BIOMET ORTHOPEDICS, INC. WHO HAS SUPPLIED THE IMPLANT. THE CALLER'S CURRENT PHYSICIAN DOES NOT FEEL QUALIFIED TO PERFORM SURGERY AND WANTS TO REFER TO ANOTHER ORTHOPEDIC PHYSICIAN SEVERAL HUNDRED MILES AWAY. IT IS DIFFICULT FOR CALLER TO ARRANGE FOR THIS DUE TO DISTANCE, ALTHOUGH HAS AN APPOINTMENT SET UP NEXT WEEK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ST GOBAIN TOTAL HIP REPLACEMENT WITH MODULAR CERAMIC HEAD JDI CERAMIQUES AVANCEES DESMARQUES TYPE 1 TAPER, 28MM HEAD, STANDARD NECK, ZIRCONIA 310460
    2 * RING LOT WITH ACETABULAR LINER HIGH WALL SIZE 23 (TIGAL 4V A KWB CERAMIQUES AVANCEES DESMARQUES 28MM 262140
    3 * UNIVERSAL RING LOCK LINER SIZE 23-2 HOLE SHELL (TIGAL 4V ALL KWB CERAMIQUES AVANCEES DESMARQUES 52MM WITH APICAL DOME HOLE 208750
    4 * LO PROFILE SELF TAPPING BONE SCREW (TIGAL 4V ALLOY) JDI CERAMIQUS AVANCEES DESMARQUES 6.5MM X 25MM 297310
    5 * LO PROFILE SELF TAPPING BONE SCREW (TIGAL 4V ALLOY) JDI CERAMIQUES AVANCEES DESMARQUES 6.5MM X 25MM 279280
    6 * BIMETRIC POROUS TYPE 1 TAPER-40 FEMORAL COLLARLESS (TIGAL 4V KWY CERAMIQUES AVANCEES DESMARQUES 14.8 X 150MM STEM 068330

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Other