BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE TOTAL A-CLASS

    MDR report key: 1013941 · Received March 12, 2008

    Report

    Report Number
    1043534-2008-00037
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 8, 2008
    Report Date
    February 8, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K051348
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETED. TRENDS WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY AND THE SURGEON. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WIL BE AMENDED WHEN THE INVESTIGATION IS COMPLETED. THIS IS THE SAME EVENT AS 1043534-2008-00036, 00038.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT BEGAN HAVING BUTTOCK DISCOMFORT IN 2007. NO ABNORMALITY ON X-RAY, NO NOISE AND NO TRAUMA. SKIN TESTS NEGATIVE FOR METAL ALLERGY. RIGHT BUTTOCK MASS DEVELOPED THE FOLLOWING MONTH, AND WAS DRAINED TWICE. TWO MONTHS LATER, UNDERWENT EXPLORATION OF RIGHT HIP WITH DRAINAGE OF FLUID. ALL FLUID ANALYSIS STILL NEGATIVE, BUT ACUTE SYNOVITIS NOTED. NO COMPONENTS CHANGED. MASS RESOLVED TEMPORARILY AND RECURRED IN EARLY 2008. ON THE FOLLOWING MONTH, UNDERWENT REVISION R THA CUP WAS EASILY REMOVED AND THERE WAS NO BONY IN-GROWTH. SYNOVITIS STILL PRESENT. PATIENT WAS CONVERTED TO METAL ON POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE TOTAL A-CLASS JDL WRIGHT MEDICAL TECHNOLOGY, INC. 115281522

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Hospitalization| R