BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12223977 · Received July 26, 2021

    Report

    Report Number
    1038671-2021-00353
    Event Type
    Injury
    Date Received
    July 26, 2021
    Date of Event
    July 2, 2021
    Report Date
    November 21, 2021
    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

    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 REVISION 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 RE-CONSTRUCTION.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICE(S): 320-15-01, 6689220 - EQ REV GLENOID PLATE; 320-20-18, S233332 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; 320-20-18, S233047 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM; 320-20-22, S227343 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; 320-20-22 S217794 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM; 320-15-05, 6847741 - EQ REV LOCKING SCREW; 320-01-38, 6900973 - EQUINOXE REVERSE 38MM GLENOSPHERE; 320-20-00, 6780160 - EQ REVERSE TORQUE DEFINING SCREW KIT; 320-10-00, 6887703 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; 300-01-13, 6859449 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM.

    Description of Event or Problem · 1

    APPROXIMATELY 2 MONTHS POSTOP THE INITIAL TSA, A REVISION CARRIED OUT AFTER THE R DISLOCATION ON THIS (B)(6) Y/O FEMALE. NEW PROTHESIS IMPLANTED SUCCESSFULLY WITH NO COMPLICATIONS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICE WILL BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1122216 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Female Hospitalization| R SEE H10