BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 2223110 · Received August 25, 2011

    Report

    Report Number
    1043534-2011-00480
    Event Type
    Injury
    Date Received
    August 25, 2011
    Date of Event
    July 22, 2011
    Report Date
    August 19, 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
    GA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. THE DEVICE HISTORY RECORD WAS REVIEWED AND INDICATES THAT PRODUCT MET SPECIFICATION WHEN MANUFACTURED. THE PRODUCT WAS NOT RETURNED.(B)(4).

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. 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 1043534-2011-00481, 00482, 00483.

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO A BROKEN COMPONENT THAT OCCURRED DURING A GAME OF TENNIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ WRIGHT MEDICAL TECHNOLOGY, INC. 066349908

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R