BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 3770184 · Received April 24, 2014

    Report

    Report Number
    3010536692-2014-00692
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    April 15, 2013
    Report Date
    April 8, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. (B)(6). TRENDS WILL BE EVALUATED. THIS IS THE SAME EVENT AS 3010536692-2014-00693, -00694, -00695. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248774 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. 076358790

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention