BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EVOLVE(R)

    MDR report key: 7929596 · Received October 3, 2018

    Report

    Report Number
    1043534-2018-00157
    Event Type
    Injury
    Date Received
    October 3, 2018
    Date of Event
    January 1, 2011
    Report Date
    September 14, 2018
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWI
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    LITERATURE CITATION: GARRIGUES ET AL. FIXATION OF THE CORONOID PROCESS IN ELBOW FRACTURE-DISLOCATIONS. THE JOURNAL OF BONE AND JOINT SURGERY. 2011; 93: 1873-81. 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 WRITTEN BY GARRIGUES ET AL. TITLED, "FIXATION OF THE CORONOID PROCESS IN ELBOW FRACTURE-DISLOCATIONS" IT WAS REPORTED THAT A RETROSPECTIVE REVIEW WAS PERFORMED AND IDENTIFIED 40 PATIENTS TREATED FOR TERRIBLE TRIAD INJURIES OF THE ELBOW WITH A MINIMUM FOLLOW-OP OF 18 MONTHS. ALL PATIENTS WERE MANAGED WITH A STANDARD APPROACH CONSISTING OF: REPAIR OR REPLACEMENT OF THE RADIAL HEAD; REPAIR OF THE LATERAL ULNAR COLLATERAL LIGAMENT (LUCL) OF THE ELBOW; AND REPAIR OF THE CORONOID FRACTURE WITH ONE OF TWO TECHNIQUES: GROUP I (N = 28) CONSISTED OF THE "LASSO" TECHNIQUE AND GROUP II (N = 12) CONSISTED OF OPEN REDUCTION AND INTERNAL FIXATION (ORIF) WITH SCREWS OR SUTURE ANCHORS. IF THE RADIAL HEAD WAS EXCISED, RADIAL HEAD ARTHROPLASTY WAS PERFORMED (IN THIRTY ELBOWS) WITH USE OF A MODULAR PROSTHESIS. THREE PATIENTS UNDERWENT REVISION SURGERY DUE TO OVERSIZED RADIAL HEAD PROSTHESIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    770829 EVOLVE(R) PROSTHESIS, ELBOW, HEMI-, RADIAL, POLYMER KWI WRIGHT MEDICAL TECHNOLOGY, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention