BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 19611460 · Received June 25, 2024

    Report

    Report Number
    1038671-2024-02128
    Event Type
    Injury
    Date Received
    June 25, 2024
    Date of Event
    May 13, 2024
    Report Date
    November 1, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    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) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): (B)(6), 300-01-09, EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM; (B)(6), 315-35-00, GLND KWIRE; (B)(6), 320-01-38, EQUINOXE REVERSE 38MM GLENOSPHERE; (B)(6), 320-10-00, EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; (B)(6), 320-15-01, EQ REV GLENOID PLATE; (B)(6), 320-15-05, EQ REV LOCKING SCREW; (B)(6), 320-20-00, EQ REVERSE TORQUE DEFINING SCREW KIT; (B)(6), 320-20-26, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; (B)(6), 320-20-26, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; (B)(6), 320-20-26, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM; (B)(6), 320-20-30, EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM; (B)(6), 321-20-00, EQUINOXE REVERSE SHOULDER DRILL KIT.

    Additional Manufacturer Narrative · 0

    (H3) A REVIEW OF THE STERILE CERTIFICATES WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) EQUINOXE REVERSE SHOULDER COMPONENTS (SECTION D) PEASE DISREGARD ALL DEVICE INFORMATION LISTED IN THIS SECTION. (D10) CONCOMITANT DEVICE(S): 7307437 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM, 7108768 315-35-00 - GLND KWIRE, A243553 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE, A269484 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 7297552 320-15-01 - EQ REV GLENOID PLATE, A235180 320-15-05 - EQ REV LOCKING SCREW, A205985 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT, A083553 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, A209705 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, A209789 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, S380103 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 6929121 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT, (H4) PLEASE DISRGARD.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 73 Y/O MALE PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 1 YEAR 6 MONTHS POST OP DUE TO INFECTION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNABLE TO OBTAIN IMAGES OR X-RAYS. PRODUCT NOT RETURNING: DISPOSED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    654835 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Required Intervention SEE H11