BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ REVERSE TORQUE DEFINING SCREW KIT

    MDR report key: 20633059 · Received November 7, 2024

    Report

    Report Number
    1038671-2024-04303
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    October 18, 2024
    Report Date
    October 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086518
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 320-10-05 EQUINOXE REVERSE TRAY ADAPTER PLATE +5MM 7203013. 320-38-03 145 DEGREE 38MM HUMERAL LINER +2.5 S395220. 300-01-10 EQUINOXE HUMERAL STEM 10MM PRIMARY 6007824. 320-15-02 RS GLENOID PLATE SUP. AUG 10 DEG. A188306. 320-06-38 EQUINOXE 38MM GLENOSHERE. 320-20-30 EQ REV COMPRESSION SCREW W/ CAP 4.5 X 30MM A118678. 320-20-30 EQ REV COMPRESSION SCREW W/ CAP 4.5 X 30MM S375299. 320-15-05 EQ REV LOCKING SCREW A218278.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 MONTH AND 9 DAYS POST THE FIRST REVISION SURGERY, THE PATIENT PRESENTED BACK WITH CONTINUED ISSUES WITH INSTABILITY AND PAIN. THE PATIENT UNDERWENT A SECOND REVISION. THE SURGEON HAD ISSUES WITH BEING ABLE TO GET THE TORQUE SCREW OUT OF THE HUMERAL STEM AND TRAY. IT WAS NOT FULLY RELEASED FROM THE STEM, CAUSING THE HUMERAL TRAY TO SPIN CIRCUMFERENTIALLY AROUND THE STEM. THE SURGEON REPLACED THE GLENOSPHERE WITH A LATERALIZED ONE, KEPT THE TRAY AS IT WOULD NOT RELEASE FROM THE STEM, AND IMPLANTED A CONSTRAINED LINER. THERE WAS A 5-15 MINUTE DELAY. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THE DELAY. THE SURGEON FELT HE GOT A STABLE CONSTRUCT WITH THE IMPLANTS THAT HE WAS ABLE TO EXCHANGE. HE WOULD HAVE LIKED TO BE ABLE TO RELEASE THE HUMERAL TRAY FROM THE HUMERAL STEM AND SPENT SOME TIME TRYING TO DISENGAGE THE IMPLANTS HOWEVER WAS NOT ABLE TO GET THEM TO DISENGAGE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1727513 EQ REVERSE TORQUE DEFINING SCREW KIT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086518

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Female Required Intervention SEE H11