BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 13733654 · Received March 11, 2022

    Report

    Report Number
    1038671-2022-00254
    Event Type
    Injury
    Date Received
    March 11, 2022
    Date of Event
    February 21, 2022
    Report Date
    May 19, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 320-15-01, 7074945 - EQ REV GLENOID PLATE. 320-01-38, 7131229 - EQUINOXE REVERSE 38MM GLENOSPHERE. 304-22-11, 6725412 - 10.5MM PLATFORM FX STEM RIGHT. 320-20-22, S297638 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. 321-20-00, 6984003 - EQUINOXE REVERSE SHOULDER DRILL KIT. 320-15-05, 7121475 - EQ REV LOCKING SCREW. 320-20-00, 7122557 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-10-00, 7052746 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE DISLOCATION AND SUBSEQUENT CLOSED REDUCTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND THE RESULT OF LOOSENED SUPPORTING LIGAMENTS AND MUSCLES, WHICH ALLOWED FOR DISLOCATION OCCURRING DUE TO THE SIGNIFICANT LIGAMENT RECONSTRUCTION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 MONTH POST OP INITIAL TSA, THIS (B)(6) FEMALE PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON UPSIZED THE GLENOSPHERE AND ADDED CONSTRAINED POLY. PATIENT HAD NO TUBEROSITES WHICH MAY HAVE CONTRIBUTED TO DISLOCATION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETUNING DUE TO THE HOSPITAL DISPOSING OF THEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1219543 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention| H