BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 4110366 · Received September 23, 2014

    Report

    Report Number
    3010536692-2014-01406
    Event Type
    Injury
    Date Received
    September 23, 2014
    Date of Event
    October 5, 2012
    Report Date
    September 3, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INVESTIGATION IS NOT COMPLETE; THIS REPORT WILL BE UPDATED WHEN COMPLETE. TRENDS WILL BE EVALUATED.

    Description of Event or Problem · 1

    ALLEGEDLY THE PATIENT WAS REVISED DUE TO NECK FRACTURE (LEFT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    591244 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. U0266349

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR Required Intervention