BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 18527472 · Received January 17, 2024

    Report

    Report Number
    1038671-2024-00103
    Event Type
    Injury
    Date Received
    January 17, 2024
    Date of Event
    March 1, 2023
    Report Date
    July 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 300-30-09 - EQUINOXE PRESERVE STEM 9MM: A193280. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: A335955. 320-06-42 - GLENOSPHERE 42MM: A324139. 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG: 7296337.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1, G4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: A, 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 CAUSE OF THE PATIENT¿S SHOULDER SUBLUXATION 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. SUBLUXATION 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

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 70 YEAR OLD MALE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2023 AND PRESENTED ON 01-MAR-2023 WITH INSTABILITY / SUBLUXATION - HAS HAD SEVERAL EPISODES OF FEELING IT POP OUT AND GO BACK IN. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. IT IS ALSO INDICATED THAT THE ACTION OF REVISION WAS TAKEN AND COMPONENTS TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW WERE REMOVED. NO REVISION WAS GIVEN AND THE OUTCOME OF THIS EVENT WAS REPORTED AS CONTINUING. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2052399 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male SEE H10