BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM GLENOSPHERE

    MDR report key: 18345545 · Received December 18, 2023

    Report

    Report Number
    1038671-2023-03005
    Event Type
    Injury
    Date Received
    December 18, 2023
    Date of Event
    November 27, 2023
    Report Date
    August 20, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: 6649871 - 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM 6762017 - 315-35-00 - GLND KWIRE 6783722 - 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE 6669113 - 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6689487 - 320-15-01 - EQ REV GLENOID PLATE 6732015 - 320-15-05 - EQ REV LOCKING SCREW 6807775 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT S129729 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S124391 - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S200159 - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM S110707 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S210915 - 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0 6801245 - 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT

    Additional Manufacturer Narrative · 0

    H3: INSTABILITY OCCURS WHEN THE SOFT-TISSUE STRUCTURES AROUND THE SHOULDER ARE UNABLE TO PROVIDE THE STABILITY NECESSARY FOR ADEQUATE FUNCTION. INSTABILITY MAY BE THE RESULT OF INCREASED SOFT-TISSUE LAXITY (LOOSENESS), INADEQUATE FLEXION OF THE IMPLANTS, OR IMPROPER POSITIONING OR ALIGNMENT OF THE PROSTHESES. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INSTABILITY AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED. CORRECTION: H6 CLINICAL CODE AND MEDICAL DEVICE PROBLEM CODE.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2021. THE PATIENT WAS REVISED ON (B)(6) 2023 DUE TO INSTABILITY. THE HUMERAL LINER, GLENOSPHERE, SCREW KIT AND LOCKING SCREW WERE REVISED. 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
    60354 EQUINOXE REVERSE 38MM GLENOSPHERE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention SEE H10