BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 2063462 · Received April 19, 2011

    Report

    Report Number
    1043534-2011-00163
    Event Type
    Injury
    Date Received
    April 19, 2011
    Report Date
    March 22, 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

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. COMPALINT REVIEWED. PACKAGE INSERT REVIEWED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT FELL 36 MONTHS AGO ACCIDENTALLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ WRIGHT MEDICAL TECHNOLOGY, INC. W03309027

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Hospitalization| R