BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 4943988 · Received July 27, 2015

    Report

    Report Number
    3010536692-2015-01430
    Event Type
    Injury
    Date Received
    July 27, 2015
    Date of Event
    September 26, 2007
    Report Date
    May 7, 2015
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Additional Manufacturer Narrative · 1

    REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2015-01241, -01242, -01431.

    Description of Event or Problem · 1

    ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN AND SUSPECTED LOOSE STEM AND NOTED LEG LENGTH DISCREPANCY. (RIGHT)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486893 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. U0470573

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention