BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 1844950 · Received September 6, 2010

    Report

    Report Number
    1844950
    Event Type
    Malfunction
    Date Received
    September 6, 2010
    Date of Event
    June 23, 2010
    Report Date
    September 6, 2010
    Manufacturer
    WRIGHT MEDICAL
    Product Code
    JDI
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    UT, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT WITH TOTAL HIP ARTHROSCOPY FOUR YEARS AGO. STARTING IN EARLY 2009 PATIENT HAS HAD RECURRENT PROBLEMS WITH DRAINAGE FROM HIP INCISION, DIAGNOSED TO BE A CYST/SEROMA. IN EARLY 2010 INCISION AND DRAINAGE (I&D) CULTURES WERE FOUND TO BE NEGATIVE. IN THE SUMMER OF 2010, INCISION CONTINUED TO DRAIN IN ADDITION TO PATIENT DISCOMFORT. PATIENT UNDERWENT SURGERY FOR REVISION. FOUND TO HAVE A METALLOSIS REACTION TO IMPLANT. REMOVED IMPLANT AND SENT BACK TO MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI WRIGHT MEDICAL * *

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR