BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLVE

    MDR report key: 8052696 · Received November 8, 2018

    Report

    Report Number
    1043534-2018-00172
    Event Type
    Injury
    Date Received
    November 8, 2018
    Report Date
    October 15, 2018
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: LAFLAMME ET AL. RETROSPECTIVE COHORT STUDY ON RADIAL HEAD REPLACEMENTS COMPARING RESULTS BETWEEN SMOOTH AND POROUS STEM DESIGNS. J SHOULDER ELBOW SURG. 2017; 26: 1316-1324. NEITHER THE DEVICE NOR APPLICABLE IMAGING FILMS WERE RETURNED TO THE MANUFACTURER FOR EVALUATION, THEREFORE, THE CAUSE OF THE EVENT CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    ALLEGEDLY, IN AN ARTICLE BY LAFLAMME ET AL. TITLED "RETROSPECTIVE COHORT STUDY ON RADIAL HEAD REPLACEMENTS COMPARING RESULTS BETWEEN SMOOTH AND POROUS STEM DESIGNS" IT WAS REPORTED THAT A RETROSPECTIVE STUDY WAS PERFORMED BETWEEN TWO GROUPS OF IMPLANTS: POROUS STEM AND SMOOTH STEM (EVOLVE). IT WAS REPORTED THAT 5 OUT OF 21 PATIENTS SUFFERED ANKYLOSIS. NO REVISIONS SURGERY WAS NECESSARY FOR THESE PATIENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    891595 EVOLVE PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER KWI WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention