BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 16910066 · Received May 11, 2023

    Report

    Report Number
    1038671-2023-00964
    Event Type
    Injury
    Date Received
    May 11, 2023
    Date of Event
    April 5, 2023
    Report Date
    November 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086389
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED PROBLEM AND THERE IS NO ALLEGATION AGAINST THE DEVICE. THIS CAUSE OF THE REPORTED EVENT IS MOST LIKELY PATIENT CONDITIONS, HOWEVER; CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 6598770 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. 6551880 315-35-00 - GLND KWIRE. 6567632 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 6571178 320-15-01 - EQ REV GLENOID PLATE. 6629013 320-15-05 - EQ REV LOCKING SCREW. 6624035 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S084091 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. S084832 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM. S059578 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. S063506 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 6553066 320-38-03 - EQUINOXE REVERSE 38MM HUMERAL LINER +2.5. 6564430 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2.5 YEARS POST OP INITIAL LEFT TSA, THIS 68 Y/O FEMALE PATIENT WAS REVISED. THE PATIENT HAS DEVELOPED AN ACROMIAL STRESS FRACTURE AND NEEDED HER REVERSE SHOULDER REPLACEMENT REMOVED TO DETENTION THE SHOULDER. FEMALE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT. NO ADDITIONAL INFORMATION/MEDICAL HISTORY REPORTED. UNABLE TO OBTAIN PHOTOS/X-RAYS. PRODUCT NOT RETURNING - DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1734712 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R