BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 38MM HUMERAL LINER +0

    MDR report key: 17796072 · Received September 22, 2023

    Report

    Report Number
    1038671-2023-02352
    Event Type
    Injury
    Date Received
    September 22, 2023
    Date of Event
    August 30, 2023
    Report Date
    May 29, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. 315-35-00 - GLND KWIRE 4864559, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM 4930399. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM 5113916. 315-35-00 - GLND KWIRE 5115138 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT 5146336. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 5149250. 320-15-05 - EQ REV LOCKING SCREW 5172709. 300-30-06 - EQUINOXE PRESERVE STEM 6MM 5269585. 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM 5296280. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 5358077. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 5368541. 320-15-01 - EQ REV GLENOID PLATE 5402772, 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE 5407653.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT RTSA ON (B)(6) 2018. THE PATIENT PRESENTED TO THE SURGEON'S OFFICE WITH COMPLAINTS OF PAIN AND DECREASED ROM. UPON EXAMINATION AND IMAGING REVIEW FROM PREVIOUS POST-OP, AND THE RECENT OFFICE VISIT X-RAYS AND ACCORDING TO THE IMPLANT RECORD WITH A STANDARD BASEPLATE BEING USED, IT APPEARED THE GLENOSPHERE WAS NOT COMPLETELY ENGAGED AND DOWN ON THE BASEPLATE. HOWEVER, THE LOCKING SCREW WAS STILL ENGAGED AND GAVE THE SURGEON A FALSE FEEDBACK IN THE INITIAL SURGERY THAT THE IMPLANT WAS DOWN AND SECURE. THE IMPLANT WAS NOT DOWN COMPLETELY AND SECURE, AND OVER TIME THE GLENOSPHERE LOCKING SCREW DISENGAGED FROM THE MECHANISM AND THE GLENOSPHERE IMPLANT LEVERAGED OFF OF THE GLENOID BASEPLATE. THERE WAS/IS EVIDENCE OF HUMERAL POLY LINER WEAR AND BONE RESORPTION/OSTEOLYSIS AROUND THE IMPLANTS. THE PATIENT WAS REVISED ON (B)(6) 2023. DURING THE REVISION, THE PATIENT'S SHOULDER JOINT AND SURROUNDING TISSUE SHOWED METALLOSIS, AND THE JOINT AND TISSUES WERE DEBRIDED. THE BROKEN AND DISENGAGED IMPLANTS WERE REMOVED. THE HUMERAL STEM WAS TESTED FOR STABILITY. THE GLENOID BASEPLATE SHOWED TO BE STABLE, SO THE SURGEON RE-IMPLANTED A REVERSE GLENOSPHERE, LOCKING SCREW, HUMERAL TRAY, AND LINER. THE PATIENT'S SHOULDER JOINT WAS IRRIGATED WELL AND CLOSED. ALL FRAGMENTS, PARTS AND PIECES WERE REMOVED. THERE WAS A 5-15 MINUTE DELAY AS THE SURGEON HAD TO SPEND EXTRA TIME CLEANING OUT/DEBRIDING THE JOINT AND SURROUNDING TISSUE. THE SURGEON TOOK EXTRA TIME TO MAKE SURE THAT THE GLENOSPHERE WAS ENGAGED ONTO THE BASEPLATE BEFORE INSERTING A NEW GLENOSPHERE SCREW. THE PATIENT LEFT THE OR STABLE. THE PATIENT REQUIRED PROLONGED HOSPITALIZATION AS A DIRECT RESULT OF THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628258 EQUINOXE REVERSE 38MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1