BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM HUMERAL LINER +0

    MDR report key: 17840734 · Received September 28, 2023

    Report

    Report Number
    1038671-2023-02396
    Event Type
    Injury
    Date Received
    September 28, 2023
    Date of Event
    September 8, 2023
    Report Date
    September 28, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. D10: 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM 4871212. 315-35-00 - GLND KWIRE 5665128. 300-30-07 - EQUINOXE PRESERVE STEM 7MM 6052357. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 6244432. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 6249412. 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG 6290855. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 6332698. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 6355235. 320-15-05 - EQ REV LOCKING SCREW 6362142. 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE 6391040. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6405124. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT 6418516. 315-35-00 - GLND KWIRE 6431460.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2020. THE PATIENT WAS REVISED (B)(6) 2023 AND THE SURGEON DISCOVERED THE HUMERAL LINER WAS DISENGAGED FROM THE HUMERAL TRAY. THE SURGEON ALSO NOTED THE POLY HAS AN ODD WEAR PATTERN AND ASKED FOR THIS TO BE INVESTIGATED. A NEW LINER WAS IMPACTED AND THE PATIENT WAS REDUCED AND CLOSED. THE SAME LINER WAS USED IN THE REVISION SURGERY AS THE ORIGINAL. 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
    352792 EQUINOXE REVERSE 42MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention SEE H10