BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 18927418 · Received March 18, 2024

    Report

    Report Number
    1038671-2024-00550
    Event Type
    Injury
    Date Received
    March 18, 2024
    Date of Event
    February 16, 2024
    Report Date
    January 8, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086662
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 6734189 - 320-02-38 - RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET. 7210419 - 320-10-10 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10. 6259218 - 320-10-15 - HUMERAL TRAY +15MM. 7253808 - 320-15-05 - EQ REV LOCKING SCREW. 7271419 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. 7271433 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S311116 - 320-38-00 - 145-DEG PE 38MM HUM LINER +0. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 62 YO MALE PATIENT, WHO HAD AN INITIAL RTSA ON (B)(6) 2020, AND HAD A REVISION PROCEDURE ON (B)(6) 2022, UNDERWENT A 2ND REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 1 YEAR 11 MONTHS POST THE FIRST REVISION IN (B)(6) 2022. THE PATIENT DID VERY WELL FOR ABOUT 2 YEARS, UNTIL HE RECENTLY DISLOCATED, CAUSING THIS REVISION. THE PATIENT WAS REVISED TO A 42MM +4MM GLENOSPHERE, NEW LOCKING SCREW, +0MM 38MM CONSTRAINED LINER, +15MM TRAY AND NEW REVERSE TORQUE SCREW. FIBER TAPE CERCLAGE WAS ALSO USED AROUND PROXIMAL HUMERUS AND TRAY. THERE WERE NO DEVICE BREAKAGES DURING THE PROCEDURE. THERE WAS A 30-45 MINUTE SURGICAL DELAY DURING THE PROCEDURE WITH NO ADVERSE EVENT TO THE PATIENT AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS WERE ABLE TO BE OBTAINED. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS AS THE HOSPITAL IS KEEPING THE DEVICES. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION. THE (B)(6) 2022 REVISION PROCEDURE WAS REPORTED UNDER MDR #1038671-2024-00546.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2317486 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 UNK 10885862086662

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| H SEE H10