BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 17322286 · Received July 13, 2023

    Report

    Report Number
    1038671-2023-01659
    Event Type
    Injury
    Date Received
    July 13, 2023
    Date of Event
    May 25, 2023
    Report Date
    December 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086389
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED MALFUNCTION AND THERE IS NO ALLEGATION AGAINST THE DEVICE. IMPLANTATION OF A TOTAL JOINT COULD RESULT SCAPULAR NOTCHING AND DISLOCATION. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS PATIENT CONDITIONS.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 5143706 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM. 5048172 315-35-00 - GLND KWIRE. 5048206 315-35-00 - GLND KWIRE. 5201214 315-35-00 - GLND KWIRE. 3909106 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5. 4838417 320-15-03 - RS GLENOID PLATE POST AUG, 8 DEG, LEFT. 5158524 320-15-05 - EQ REV LOCKING SCREW. 5140945 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. 5103634 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. 5190833 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. 5011600 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 5171651 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. 3874478 320-38-10 - EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0. 5175206 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2018. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO REPEAT DISLOCATIONS. NEW REVERSE COMPONENTS WERE IMPLANTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    196263 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 320-01-38 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Required Intervention| H SEE H10