BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 2030022 · Received March 25, 2011

    Report

    Report Number
    1043534-2011-00090
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 15, 2011
    Report Date
    April 4, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION/CORRECTED DATA RECEIVED (B)(4) 2012: ADDITIONAL INFORMATION RECEIVED THAT THIS COMPONENT WAS NOT FRACTURED. (B)(4) NO KNOWN DEVICE PROBLEM.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500A HAS BEEN RECEIVED. TRENDS WILL BE EVALUATED. 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 1043534-2011-00091, 00092.

    Description of Event or Problem · 1

    ALLEGEDLY THE COMPONENT BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ WRIGHT MEDICAL TECHNOLOGY, INC. 058600594

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R