BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLVE

    MDR report key: 8061485 · Received November 12, 2018

    Report

    Report Number
    1043534-2018-00181
    Event Type
    Injury
    Date Received
    November 12, 2018
    Report Date
    October 15, 2018
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: SCHNETZKE ET AL. RADIAL HEAD PROSTHESIS IN COMPLEX ELBOW DISLOCATIONS: EFFECT OF OVERSIZING AND COMPARISON WITH ORIF. INTERNATIONAL ORTHOPAEDICS. 2014; 38: 2295-2301. 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 FROM 2015 BY SCHNETZKE ET AL. TITLED "INFECTED TAR: RISK FACTORS AND TREATMENT OPTIONSRADIAL HEAD PROSTHESIS IN COMPLEX ELBOW DISLOCATIONS: EFFECT OF OVERSIZING AND COMPARISON WITH ORIF" 30 PATIENTS UNDERWENT SURGERY WITH EVOLVE. IT WAS REPORTED THAT 90% DEVELOPED AT LEAST ONE RADIOGRAPHIC ABNORMALITY, 20% HAD SECONDARY DISLOCATION/SUBLUXATION ON X-RAYS, 63% HAD RADIOLUCTENT LINES ON X-RAYS, 20% HAD HO, AND 53% HAD HETEROTOPIC OSSIFICATIONS ON X-RAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901058 EVOLVE PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER KWI WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1