BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 2063490 · Received April 19, 2011

    Report

    Report Number
    1043534-2011-00162
    Event Type
    Injury
    Date Received
    April 19, 2011
    Date of Event
    January 21, 2011
    Report Date
    March 18, 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
    FR
    Reporter Occupation
    OTHER

    Narratives

    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).

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. PACKAGE INSERT REVIEWED. PRODUCT NOT RETURNED.

    Description of Event or Problem · 1

    ALLEGEDLY SPONTANEOUS RUPTURE WITHOUT ADEQUATE TRAUMA.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R