BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS

    MDR report key: 1991940 · Received February 15, 2011

    Report

    Report Number
    1043534-2011-00065
    Event Type
    Injury
    Date Received
    February 15, 2011
    Date of Event
    January 17, 2011
    Report Date
    January 17, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K051348
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00064.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. VISUAL EXAMINED. COMPLAINT REVIEWED AND ANALYSIS SHOWED NO TREND FOR 38AM5000 LOT NO: 058592704. DEVICE HISTORY RECORD REVIEWED.

    Description of Event or Problem · 1

    ALLEGEDLY REMOVED DURING THE REVISION OF ANOTHER COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL A-CLASS HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 058592704

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R