BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 19917291 · Received August 6, 2024

    Report

    Report Number
    1038671-2024-02699
    Event Type
    Injury
    Date Received
    August 6, 2024
    Date of Event
    April 29, 2024
    Report Date
    August 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM: 5738878. 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE: 5834205. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 5780355. 320-15-01 - EQ REV GLENOID PLATE: 5391862. 320-15-05 - EQ REV LOCKING SCREW: 5942311. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 5941197. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 5793551. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 5885642. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM: 5926002. 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM: 5695823. 320-38-13 - EQUINOXE REVERSE 38MM HUMERAL CONST LINER +2.5: 5731800.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. THE REASON FOR THE PAIN REPORTED CANNOT BE CONCLUSIVELY. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. 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

    APPROXIMATELY 5 YEAR(S), 0 MONTH(S) AND 8 DAY(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH UNEXPLAINED PAIN IN THE RIGHT SHOULDER. THE PATIENT PUSHED UP OUT OF BED, PAIN IN RIGHT SHOULDER. THERE WERE NO ACTIONS TAKEN AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703320 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female SEE H11.