BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 1840433 · Received September 21, 2010

    Report

    Report Number
    1043534-2010-00383
    Event Type
    Injury
    Date Received
    September 21, 2010
    Date of Event
    July 20, 2010
    Report Date
    November 8, 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
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE DEVICE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN (B)(6).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO DEVICE FAILURE. DIMENSIONAL INSPECTION. FUNCTIONAL CHECK. USE OF DEVICE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY DISASSEMBLY OF THE FEMORAL HEAD AND OF THE MODULAR NECK IN THE MEAFIASIARIA PART.

    Description of Event or Problem · 1

    ALLEGEDLY DISASSEMBLY OF THE FEMORAL HEAD AND OF THE MODULAR NECK IN THE MEAFIASIARIA PART.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ WRIGHT MEDICAL TECHNOLOGY, INC. 097471739

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R