BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) COCR NECK

    MDR report key: 3201884 · Received July 2, 2013

    Report

    Report Number
    1043534-2013-01104
    Event Type
    Injury
    Date Received
    July 2, 2013
    Report Date
    May 31, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-01102, 01103, 01105.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED. THE PRODUCT WAS NOT RETURNED.(B)(4).

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT REVISED FOR SYMPTOMATIC PAIN AND ELEVATED IONS DUE TO MOM BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    301279 PROFEMUR(R) COCR NECK HIP COMPONENT, CODE:LWJ LWJ WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention