BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) COCR NECK

    MDR report key: 3802268 · Received May 9, 2014

    Report

    Report Number
    3010536692-2014-00770
    Event Type
    Injury
    Date Received
    May 9, 2014
    Date of Event
    May 3, 2014
    Report Date
    May 6, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KWA
    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).

    Additional Manufacturer Narrative · 1

    REVIEW OF PHOTOGRAPHS.

    Description of Event or Problem · 1

    ALLEGEDLY BROKEN NECK, DURING GOING DOWNSTAIRS, NOT FALLEN. ADD'L INFO REC'D (B)(4) 2014: THE PT. WAS ADMITTED WITH A BROKEN NECK WITHOUT ANY TRAUMA. HE WENT A STEP DOWN AND THE NECK BROKE. DR. (B)(6) IS A VERY EXPERIENCED SURGEON WITH MODULARITY AND HE IS VERY ACCURATE WITH THE IMPLANTS AND THE IMPLANTATION. EVERY NECK AND POCKET IS DRY AND CLEAN. HIGH ACTIVITY LEVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280914 PROFEMUR(R) COCR NECK HIP COMPONENT KWA MICROPORT ORTHOPEDICS INC. 1453706

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention