BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 3130177 · Received May 24, 2013

    Report

    Report Number
    1043534-2013-00918
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    January 26, 2012
    Report Date
    April 24, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    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).

    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 1043534-2013-00917, 00919. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY ON (B)(6) 2011, THE PATIENT HAD A LOT OF "TUMENTIA" AND HYDROPS. REVISION SURGERY WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232846 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT, CODE:LWJ LWJ WRIGHT MEDICAL TECHNOLOGY, INC. 0701172552

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention