BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) COCR NECK

    MDR report key: 4192494 · Received October 22, 2014

    Report

    Report Number
    3010536692-2014-01513
    Event Type
    Injury
    Date Received
    October 22, 2014
    Date of Event
    February 3, 2014
    Report Date
    October 13, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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

    THIS IS THE SAME EVENT AS 3010536692-2014-01514, -0515, -0516. THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY, THE PATIENT WAS REVISED DUE TO PAIN AND PSEUDOTUMOR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    672219 PROFEMUR(R) COCR NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 0211294979

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention