BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CONSERVE(R) TOTAL A-CLASS HEAD

    MDR report key: 1971223 · Received January 26, 2011

    Report

    Report Number
    1043534-2011-00025
    Event Type
    Injury
    Date Received
    January 26, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 23, 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
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: PRODUCT DID NOT CONTRIBUTE TO EVENT.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUTED. NO COMPLAINT WAS STATED AGAINST THIS DEVICE. ADDITIONAL INFORMATION HAS BEEN REQUESTED FROM THE USER FACILITY. 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 1043534-2011-00023, 00024, 00026.

    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 JDL WRIGHT MEDICAL TECHNOLOGY, INC. 085256574

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R