BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS

    MDR report key: 1960520 · Received January 13, 2011

    Report

    Report Number
    1043534-2011-00006
    Event Type
    Injury
    Date Received
    January 13, 2011
    Date of Event
    December 15, 2010
    Report Date
    December 13, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    PMA / PMN Number
    K051348
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECIEVED FROM THE USER FACILITY. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2011-00005, 00007.

    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. 028542261

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R