BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 3051303 · Received April 10, 2013

    Report

    Report Number
    1043534-2013-00646
    Event Type
    Injury
    Date Received
    April 10, 2013
    Date of Event
    June 15, 2009
    Report Date
    March 1, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC
    Product Code
    LWJ
    PMA / PMN Number
    K003016
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. 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 1043534-2013-00645, 00647, 00648.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.THE COMPLAINT AND PACKAGE INSERT WERE REVIEWED. THE PRODUCT WAS NOT RETURNED.EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.(B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY REVISED DUE TO METAL ON METAL COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    152331 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT, CODE:LWJ LWJ WRIGHT MEDICAL TECHNOLOGY, INC 088580814

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Female Required Intervention