BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 1882121 · Received October 25, 2010

    Report

    Report Number
    1043534-2010-00418
    Event Type
    Injury
    Date Received
    October 25, 2010
    Date of Event
    September 9, 2010
    Report Date
    July 8, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.PRODUCT CONFORMANCE COULD NOT BE DETERMINED.USE OF DEVICE COULD NOT BE DETERMINED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, A MEDWATCH 3500A HAS NOT BEEN RECEIVED FROM THE USER FACILITY. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2010-00419.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED, DUE TO A BROKEN COMPONENT.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO A BROKEN COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ WRIGHT MEDICAL TECHNOLOGY, INC. U0671648

    Patients

    Seq Age Sex Outcome Treatment
    1 49 YR Hospitalization| R