BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

    MDR report key: 19777690 · Received July 18, 2024

    Report

    Report Number
    1038671-2024-02449
    Event Type
    Injury
    Date Received
    July 18, 2024
    Date of Event
    June 26, 2024
    Report Date
    May 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086419
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 300-30-12 - EQUINOXE PRESERVE STEM 12MM: 5151395. 315-35-00 - GLND KWIRE: 5191953. 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE: 5178049. 320-15-05 - EQ REV LOCKING SCREW: 4953908. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 5182471. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 5124051. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 5124053. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: 5124397. 531-20-00 - SHLDR GPS RVRS DRILL KIT: 5007839. A10012 - GPS IMPLANT KIT V2: 10000017186.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REVISION REPORTED MAY HAVE BEEN DUE TO DISASSEMBLY OF THE HUMERAL LINER FROM THE HUMERAL HEAD, AND/OR LOOSENING OF THE GLENOID BASEPLATE. HOWEVER, THE REPORTED DISASSEMBLY AND GLENOID LOOSENING COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, AND PATIENT-RELATED CONSIDERATIONS, AN UNREPORTED TRAUMATIC EVENT, INCOMPLETE SEATING OF THE HUMERAL LINER DURING IMPLANTATION, FORCEFUL CONTACT BETWEEN THE LINER AND GLENOID BONE (SCAPULAR NOTCHING), OR A COMBINATION OF THE ABOVE TO THE REPORTED EVENT CANNOT BE DETERMINED, AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, RELEVANT CLINICAL INFORMATION, AND PRODUCT INFORMATION WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    APPROXIMATELY 6 YEAR(S), 3 MONTH(S) AND 27 DAY(S) POST-OPERATIVE OF A RIGHT TSA, THE PATIENT PRESENTED WITH DISASSOCIATION OF POLYETHYLENE. SUBJECT PRESENTED WITH EXTRUDED POLY FROM TRAY AFTER USING HEAVY HEDGER; DURING SURGERY IT WAS NOTED THAT BASEPLATE WAS ALSO LOOSE. THE PATIENT UNDERWENT STANDARD REVERSE WITH PRESERVE STEM REVISION SURGERY AND THE OUTCOME IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2032082 EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086419

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male SEE H11