BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 22158204 · Received June 6, 2025

    Report

    Report Number
    1038671-2025-02244
    Event Type
    Injury
    Date Received
    June 6, 2025
    Date of Event
    May 9, 2025
    Report Date
    August 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: A598365 320-15-01 - EQ REV GLENOID PLATE A755409 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE A785319 315-35-00 - GLND KWIRE A802675 321-52-07 - 3.2MM DRILL BIT STERILE A891570 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM A894890 320-15-05 - EQ REV LOCKING SCREW A937285 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A957563 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM S467263 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM S510490 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6, H11. THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6. THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED, A 68 YO FEMALE, WHO HAD A RIGHT SHOULDER IMPLANTED, UNDERWENT REVISION PROCEDURE. THE PATIENT DISLOCATED IN EARLY (B)(6) AND THE SHOULDER WAS REVISED TO INCREASE THE OFFSET. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. X-RAYS WERE PROVIDED. NO FURTHER INFORMATION. THIS IS 1 OF 2 EVENTS. SEE MDR#1038671-2025-02243.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1392510 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Required Intervention