BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 1920375 · Received December 10, 2010

    Report

    Report Number
    1043534-2010-00513
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    November 11, 2010
    Report Date
    November 11, 2010
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED AND INDICATES THAT PRODUCT MET SPECIFICATION WHEN MANUFACTURED. PRODUCT NOT RETURNED FOR EVALUATION. NO CONCLUSIONS CAN BE REACHED WITH THE INFORMATION PROVIDED. NO CORRECTIVE ACTION REQUIRED AS ANALYSIS SHOWS NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT DEVICE CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00512.

    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 HEAD HIP COMPONENT KWA WRIGHT MEDICAL TECHNOLOGY, INC. 106372052

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R