BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 18861698 · Received March 7, 2024

    Report

    Report Number
    1038671-2024-00433
    Event Type
    Injury
    Date Received
    March 7, 2024
    Date of Event
    March 3, 2023
    Report Date
    August 12, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-30-14 - EQUINOXE PRESERVE STEM 14MM: 5623800 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5: A084553 320-08-42 - GLENOSPHERE EXP 42MM +4MM OFFSET: A203815 320-15-05 - EQ REV LOCKING SCREW: A235657 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: A230098 (H3) PENDING EVALUATION

    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, D4, G4, H6 MDR SECTION CODES UPDATED/CORRECTED: B, C, D, 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 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

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD A RIGHT TSA ON (B)(6) 2022 AND PRESENTED WITH DISLOCATION, ON (B)(6) 2023. PT PRESENTED AT OFFICE 3 WKS AFTER CLOSED REDUCTION WITH DISOLCATED REVERSE. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED ON (B)(6) 2023. THE ACTION TAKEN WAS REVISION-STANDARD REVERSE W-PRESERVE STEM WITH THE REMOVAL OF THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    880848 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Male