BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8633198 · Received May 22, 2019

    Report

    Report Number
    1038671-2019-00284
    Event Type
    Injury
    Date Received
    May 22, 2019
    Date of Event
    April 26, 2019
    Report Date
    May 22, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862186768
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVISION REPORTED WAS LIKELY THE RESULT OF CALCIFICATION OF THE DELTOID, WHICH LED TO REPEATED DISLOCATION OF THE SHOULDER. THIS IS A CLINICAL EVENT THAT DOES NOT APPEAR TO BE RELATED TO THE DESIGN, MANUFACTURING, OR REASONABLY FORESEEABLE MISUSE OF THE DEVICES. THEREFORE, DHRS AND STERILIZATION RECORDS WILL NOT BE REVIEWED. IN A REVIEW OF THE LABELING AND IFU 700-096-060 REV. M - CONTRAINDICATION - INADEQUATE OR MALFORMED BONE THAT PRECLUDES ADEQUATE SUPPORT OR FIXATION OF THE PROSTHESIS. ALSO, AS PART OF THE PRE-OPERATIVE ASSESSMENT, THE SURGEON MUST ENSURE THAT NO BIOLOGICAL, BIOMECHANICAL, OR OTHER FACTORS EXIST THAT MIGHT ADVERSELY AFFECT THE SURGERY AND/OR THE POSTOPERATIVE PERIOD. SURGICAL INTERVENTIONS/REVISIONS ARE WELL KNOWN RISKS FOR JOINT ARTHROPLASTY. CONCOMITANT MEDICAL DEVICES: 320-10-05, 5698051 - HUMERAL TRAY, +5; 320-42-00, 5899120 - HUMERAL LINER, 42MM, +0; 320-20-00, NOT REPORTED - TORQUE SCREW; 320-15-05, 5828006 - GLENOSPHERE LOCKING SCREW; 320-15-06, 5259280 - SUP/POST AUG BASEPLATE; 320-15-34, 5771383 - 34MM SCREW; 320-15-34, 5840229 - 34MM SCREW; 320-20-18, 5860034 - 18MM SCREW; 320-20-26, 5766482 - 26MM SCREW; 320-11-00, NOT REPORTED - 11MM SCREW.

    Description of Event or Problem · 1

    REVISION PERFORMED ON (B)(6) 2019. THIS SHOULDER WAS DISLOCATING DUE TO CALCIFICATION OF THE DELTOID WHICH KEPT PUSHING THE HUMERUS ANTERIOR AND DISLOCATING THE SHOULDER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    424188 EQUINOXE RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET KWT EXACTECH, INC. 10885862186768

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention