BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZIMMER

    MDR report key: 568209 · Received January 24, 2005

    Report

    Report Number
    MW1034437
    Event Type
    Malfunction
    Date Received
    January 24, 2005
    Date of Event
    December 23, 2004
    Report Date
    January 14, 2005
    Manufacturer
    ZIMMER
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    PA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    ELECTIVE SURGERY TO REMOVE BROKEN HIP STEM AND REVISION WORK; THREE DEVICES REMOVED.

    Description of Event or Problem · 1

    ADD'L INFO REC'D FROM MFR 3/7/2005: THE DEVICES WERE IMPLANTED FOR 14-1/2 MONTHS. BRAND NAME, OF EACH DEVICE INVOLVED IN THIS EVENT REPORT. CATALOG NUMBER: 00-9981-180-33 ZMR HIP SYSTEM FEMORAL STEM, POROUS STEM, 18.0 X 220MM, BOWED; 00-9993-017-45 ZMR HIP SYSTEM FEMORAL BODY, CONE BODY, 46 X 45MM NECK; 00-8018-032-01 VERSYS HIP SYSTEM FEMORAL HEAD; 00-2232-001-28 CABLE-READY CABLE GRIP SYSTEM CERCLAGE CABLE; 00-2232-002-05 CABLE-READY INTEGRAL LONG GTR W/4 CABLES. MDR NUMBER 1822565-2005-00005 WAS SUBMITTED TO THE FDA ON FEB 1, 2005.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZIMMER ARTIFICIAL HIP FEMORAL STEM JDI ZIMMER * 69378300
    2 ZIMMER ARTIFICIAL HIP, FEMORAL BODY/NECK JDI ZIMMER * 60047620
    3 ZIMMER ARTIFICIAL HIP, FEMORAL HEAD JDI ZIMMER * 60062004
    4 ZIMMER ARTIFICIAL HIP, CABLE JDI ZIMMER * 7191400
    5 ZIMMER ARTIFICIAL HIP, CABLE JDI ZIMMER * 52153000
    6 ZIMMER ARTIFICIAL HIP, CABLE JDI ZIMMER * 75538700
    7 ZIMMER ARTIFICIAL HIP, TROCHANTERIC REATTACHMENT DEVICE JDI ZIMMER * 77105500

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR