BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20405757 · Received October 9, 2024

    Report

    Report Number
    1038671-2024-03888
    Event Type
    Injury
    Date Received
    October 9, 2024
    Date of Event
    September 24, 2024
    Report Date
    July 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    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

    PENDING INVESTIGATION. D10: 321-52-07 - 3.2MM DRILL BIT STERILE A431071 300-30-07 - EQUINOXE PRESERVE STEM 7MM A662565 321-52-09 - 3.2MM K-WIRE, TROCAR TIP A756438 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM B000668 322-38-00 - 145-DEG PE 38MM HUM LINER +0 B036837 322-10-00 - HUMERAL ADAPTER TRAY, +0 B061050 320-06-38 - GLENOSPHERE 38MM B067151 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM B073478 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT B077426 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM B085703 320-15-01 - EQ REV GLENOID PLATE B106355 320-15-05 - EQ REV LOCKING SCREW B150145 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S541187.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. H3: THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 MONTH AND 2 DAYS POST THE INITIAL RIGHT RTSA, THE PATIENT DISLOCATED. THE SURGEON WAS ABLE TO PERFORM A CLOSED REDUCTION, HOWEVER, THE PATIENT'S SHOULDER WAS VERY UNSTABLE AND COULD BE DISLOCATED, SO THE SURGEON CHOSE TO REVISE SOME COMPONENTS. HE SWAPPED THE SPHERE TO AN EXPANDED AND WENT UP ON THE STEM. HE REPLACED THE TRAY, LINER, LOCKING SCREW AND TORQUE SCREW. THERE WAS NO REPORTED BREAKAGE OF A DEVICE, AND A >45 MINUTE DELAY TO THE ORIGINAL PLANNED SURGERY DUE TO THE REVISION. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    685974 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention SEE H11