BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 2243370 · Received September 12, 2011

    Report

    Report Number
    1043534-2011-00529
    Event Type
    Injury
    Date Received
    September 12, 2011
    Date of Event
    July 25, 2011
    Report Date
    September 2, 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
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    DEVICE #2: INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATION. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. 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 1043534-2011-00528, 00530.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO METAL ION LEVELS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSERVE(R) TOTAL A-CLASS HEAD HIP COMPONENT JDL WRIGHT MEDICAL TECHNOLOGY, INC. 117506075

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR Hospitalization| R