BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 17898467 · Received October 9, 2023

    Report

    Report Number
    1038671-2023-02476
    Event Type
    Injury
    Date Received
    October 9, 2023
    Date of Event
    September 15, 2023
    Report Date
    July 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: A430775 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 6620410 300-01-17 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 17MM, 7105412 320-15-05 - EQ REV LOCKING SCREW, 7193087 320-15-07 - SUP/POST AUG PLATE, L RS GLENOID BASEPLATE, A368649 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, A384154 320-08-42 - GLENOSPHERE EXP 42MM +4MM OFFSET, S074352 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, S095185 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM, S214272 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, S241702 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. 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. 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 THAT A MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2023, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2023. THE PATIENT DISLOCATED THEIR REVERSE SHOULDER DUE TO SOFT TISSUE LOOSENING AND WAS REVISED TO A +2.5 42MM HUMERAL LINER AND A +5 HUMERAL TRAY. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS REPORTED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    942448 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +0 UNK

    Patients

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