BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) COCR NECK

    MDR report key: 3980224 · Received August 5, 2014

    Report

    Report Number
    3010536692-2014-01023
    Event Type
    Injury
    Date Received
    August 5, 2014
    Date of Event
    July 9, 2014
    Report Date
    July 10, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 3010536692-2014-01024, 01025, 01026.

    Additional Manufacturer Narrative · 1

    REMOVE THE FOLLOWING NARRATIVE FROM THIS INCIDENT AS IT DOES NOT APPLY: THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY PT COMPLAINED OF HIP PAIN - THOUGHT TO BE INFECTED - REVISED. DR. (B)(6) WANTS TO CHECK FOR ALVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    458326 PROFEMUR(R) COCR NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 08977218101

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention