BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 4141113 · Received October 3, 2014

    Report

    Report Number
    3010536692-2014-01452
    Event Type
    Injury
    Date Received
    October 3, 2014
    Date of Event
    July 9, 2014
    Report Date
    September 3, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY, THE PT WAS STEPPING INTO AN AMBULANCE (AS A PSYCHIATRIC NURSE). HE TWISTED HIS LEG. WHEN HE ARRIVED AT THE HOSPITAL, IT TURNED OUT THAT THE NECK OF THE PROSTHESIS WAS BROKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    619397 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. 17935/6148?

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention