BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 19153877 · Received April 22, 2024

    Report

    Report Number
    1038671-2024-00922
    Event Type
    Injury
    Date Received
    April 22, 2024
    Date of Event
    April 4, 2024
    Report Date
    August 13, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862172686
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 4243603 - 300-01-15 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM. 4008861 - 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S. 4231975 - 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 3850838 - 310-01-47 - EQUINOXE, HUMERAL HEAD SHORT, 47MM (BETA). 3693572 - 14-13-03 - EQUINOXE CAGE GLENOID MEDIUM, ALPHA. 4201245 - 315-35-00 - GLND KWIRE.

    Additional Manufacturer Narrative · 0

    H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF THE PATIENT¿S ROTATOR CUFF TEAR. THE REASON FOR THE OBSERVED FRACTURE OF THE GLENOID COMPONENT COULD NOT BE DETERMINED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A MALE PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6) 2016, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 7 YEARS 11 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT HAD A PREVIOUS TOTAL SHOULDER REPLACEMENT THEN FAILED ROTATOR CUFF WHICH REQUIRED THE CHANGE TO A REVERSE SHOULDER REPLACEMENT. EVERYTHING WAS REMOVED. IMAGE OF DEVICE PROVIDED APPEARED TO BE FRACTURED WHICH WAS REPORTED TO BE FOUND UPON OPENING THE WOUND SITE. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. NO X-RAYS WERE ABLE TO BE OBTAINED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS AS THEY WERE DISCARDED AT THE HOSPITAL. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1081964 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE CAGE GLENOID MEDIUM, ALPHA UNK 10885862172686

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10