BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 18335051 · Received December 15, 2023

    Report

    Report Number
    1038671-2023-02996
    Event Type
    Injury
    Date Received
    December 15, 2023
    Date of Event
    November 28, 2023
    Report Date
    July 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K110708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 6109604 300-30-10 - EQUINOXE PRESERVE STEM 10MM 5910842 315-35-00 - GLND KWIRE 6246195 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6189114 320-15-01 - EQ REV GLENOID PLATE 6217243 320-15-05 - EQ REV LOCKING SCREW 6241004 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6220923 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM 6244912 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 6232647 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 6151949 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM 6145150 320-38-03 - EQUINOXE REVERSE 38MM HUMERAL LINER +2.5

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. D10: (B)(6) 320-02-38 - RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET (B)(6) 300-30-10 - EQUINOXE PRESERVE STEM 10MM (B)(6) 315-35-00 - GLND KWIRE (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) 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (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) 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM (B)(6) 320-38-03 - EQUINOXE REVERSE 38MM HUMERAL LINER +2.5. H3: THE CAUSE OF THE PATIENT¿S SHOULDER INSTABILITY 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. INSTABILITY IS A KNOWN RISK, AS OUTLINED IN THE IFU.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL TSA ON (B)(6) 2019. THE PATIENT COMPLAINED OF INSTABILITY AND WAS REVISED ON (B)(6) 2023. EVENT OCCURRED OVER TIME. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2301741 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Male Required Intervention SEE H10| SEE H11