BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 2080750 · Received May 6, 2011

    Report

    Report Number
    1043534-2011-00196
    Event Type
    Injury
    Date Received
    May 6, 2011
    Date of Event
    March 30, 2011
    Report Date
    April 7, 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
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 1043534-2011-00197, 00198.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. VISUALLY EXAMINED. COMPLAINT REVIEWED. DEVICE HISTORY RECORD REVIEWED. PACKAGE INSERT REVIEWED. TECHNICAL REPORT COMPLETED. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED. UNDETERMINED.

    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. 028546978

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R