BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TOTAL HIP

    MDR report key: 456223 · Received April 24, 2003

    Report

    Report Number
    MW1028239
    Event Type
    Malfunction
    Date Received
    April 24, 2003
    Date of Event
    January 17, 2003
    Report Date
    April 10, 2003
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY INC.
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    A REP FROM WRIGHT MEDICAL TECHNOLOGY, INC. ATTENDING THE TOTAL HIP SURGERY BROUGHT THE WRONG FEMORAL HEAD (NON FINE-FINISHED) FOR THE HIP SOCKET INTO THE OPERATING ROOM, WHICH WAS PLACED INTO THE PT. WRIGHT MEDICAL CONTACTED THE SURGEON AT 7:00PM 3 DAYS LATER TO ADVISE HIM THEY DISCOVERED THE MISTAKE. PT WAS NOTIFIED IN 01/2003 AND SCHEDULED FOR SURGERY IN 2003.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TOTAL HIP TOTAL HIP JDI WRIGHT MEDICAL TECHNOLOGY INC. NA 09228995

    Patients

    Seq Age Sex Outcome Treatment
    1 *