BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 1920333 · Received December 10, 2010

    Report

    Report Number
    1043534-2010-00508
    Event Type
    Injury
    Date Received
    December 10, 2010
    Date of Event
    July 12, 2010
    Report Date
    July 26, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWA
    PMA / PMN Number
    K021349
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED FROM THE USER FACILITY. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 10435354-201000507, 00509.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.PRODUCT NOT RETURNED. COMPLAINT HISTORY REVIEWED. DEVICE HISTORY RECORD REVIEWED. PACKAGE INSERT REVIEWED. EVIDENCE THAT PRODUCT IN SPEC WHEN USED. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO PAIN.

    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. 016281531

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR Hospitalization| R