BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 42MM HUMERAL LINER +0

    MDR report key: 19409629 · Received May 28, 2024

    Report

    Report Number
    1038671-2024-01510
    Event Type
    Injury
    Date Received
    May 28, 2024
    Date of Event
    May 3, 2024
    Report Date
    May 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 300-30-06 - EQUINOXE PRESERVE STEM 6MM : 7080219. 320-06-42 - GLENOSPHERE 42MM : 7272916. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 : 7299679. 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE : 7266644. 320-15-05 - EQ REV LOCKING SCREW : 7117738. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT : 7294308. 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM : S345345. 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM : S297027. 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM : S301226.

    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, D1/D2A/D2B, H6. MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, G. THE REVISION REPORTED MAY HAVE BEEN DUE TO DISASSEMBLY OF THE HUMERAL LINER FROM THE HUMERAL TRAY, AND/OR LOSS OF RANGE OF MOTION. HOWEVER, THE REPORTED DISASSEMBLY AND LOSS OF RANGE OF MOTION COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT, 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 DISASSEMBLY OF THE HUMERAL LINER CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL 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

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD A RIGHT TSA IMPLANTED AND APPROXIMATELY 2 YEARS POST THEY PRESENTED WITH DISASSOCIATION OF POLYETHYLENE. THE PATIENT HAD RETRACTED THEIR SHOULDER BLADES WHILE DRIVING, AND EXPERIENCED A POP/INCREASED PAIN/DECREASED MOTION. THE PATIENT UNDERWENT A STANDARD REVERSE WITH PRESERVE STEM REVISION SURGERY IN (B)(6) 2024 AND THE TORQUE SCREW, HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW WERE REMOVED. THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED AND THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1238107 EQUINOXE REVERSE 42MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE REVERSE 42MM HUMERAL LINER +0

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Required Intervention