BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM

    MDR report key: 22135373 · Received June 3, 2025

    Report

    Report Number
    1038671-2025-02228
    Event Type
    Injury
    Date Received
    June 3, 2025
    Date of Event
    May 8, 2025
    Report Date
    October 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086532
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 308-01-06 - 6X80MM DISTAL STEM MODULAR CEMENTED: (B)(6). 320-36-13 - 145-DEG PE 36MM CONST HUM LINER +2.5: (B)(6). 320-35-02 - SMALL SUPERIOR AUGMENT GLENOID PLATE: (B)(6). 320-32-36 - EXPANDED GLENO, 36MM, FOR SMALL REVERSE: (B)(6). 320-10-00 - EQUINOXE REV TRAY ADAPTER PLATE TRAY +0: (B)(6). 320-15-05 - EQ REV LOCKING SCREW: (B)(6). 308-05-17 - DISTAL FIXATION RING HA 17.5: (B)(6). 308-09-12 - SMALL PROX BODY +12.5: (B)(6). 308-15-12 - TAPER LOCKING SCREW 12.5: 7021742 320-20-22 - EQ REV COMP SCREW LCK CAP KIT, 4.5 X 22MM: (B)(6). 320-20-22 - EQ REV COMP SCREW LCK CAP KIT, 4.5 X 22MM: (B)(6). 320-20-26 - EQ REV COMP SCREW LCK CAP KIT, 4.5 X 26MM: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D6B, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F, G. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE GLENOID BASEPLATE AND DISTAL STEM LOOSENING AS REPORTED. ALSO, THE REPORTED LOOSENING OF THE IMPLANTS MAY HAVE CAUSED THE REPORTED PAIN. HOWEVER, THE LOOSENING CANNOT BE CONFIRMED AND ANY POTENTIAL CONTRIBUTIONS FROM MANUFACTURING, USER, OR PATIENT-RELATED CONTRIBUTING FACTORS TO THE EVENT CANNOT BE EVALUATED AS NO RADIOGRAPH, IMAGES, OR CLINICAL INFORMATION WAS PROVIDED. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL REVERSE TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE WITH A COMPETITOR'S DEVICES. SUBSEQUENTLY, THE PATIENT WAS REVISED TO EXACTECH DEVICES AND HAS EXPERIENCED DISASSOCIATION OF THE GLENOSPHERE COMPONENT, APPROXIMATELY 2 YEARS AFTER THE SHOULDER REVISION. IT WAS REPORTED, THE PATIENT REACHED BEHIND CAR SEAT AND IMMEDIATELY EXPERIENCED PAIN AND THE SHOULDER FELT "STUCK." THIS RESULTED IN LOOSENING OF BASEPLATE SCREWS AND HUMERAL STEM LUCENCY. AS A RESULT, AFTER THE REVISION TO EXACTECH DEVICES, THE PATIENT REPORTEDLY UNDERWENT AN ADDITIONAL RIGHT SHOULDER REVISION BUT NO OFFICIAL DATE WAS STATED OR COULD BE LOCATED. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1065095 EQUINOXE REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086532

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization SEE H11