BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE 46MM HUMERAL LINER +0

    MDR report key: 19243920 · Received May 3, 2024

    Report

    Report Number
    1038671-2024-01050
    Event Type
    Injury
    Date Received
    May 3, 2024
    Date of Event
    April 10, 2024
    Report Date
    May 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086730
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H3: PENDING INVESTIGATION. D10: A536080 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM A454269 320-06-46 - GLENOSPHERE 46MM A579799 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A591043 320-15-04 - RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT A538272 320-15-05 - EQ REV LOCKING SCREW A560839 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT S450961 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM S450978 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM A111365 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN DUE TO DISASSEMBLY. HOWEVER, THE REPORTED DISASSEMBLY 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. B3: CORRECTED. D6: CORRECTED. H6: CORRECTED. HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 73 Y/O PATIENT'S RIGHT SHOULDER WAS REVISED APPROXIMATELY 9 MONTHS POST OP. AFTER XRAY IT WAS DETERMINED THE POLY DISASSOCIATED FROM THE TRAY. THEY ARE NOT SURE WHEN THE EVENT OCCURRED BUT THE PATIENT CAME TO THE DOCTORS OFFICE WITH PAIN AND CLICKING. THE TRAY WAS REMOVED AND THE GLENOSPHERE TAKEN OFF TO EVALUATE THE STEM AND GLENOID PLATE. BOTH WERE FOUND TO BE WELL FIXED. THEN THE SURGEON TRIALED A 42+4 AND FOUND IT TO HAVE EXCELLENT ROM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    782537 EQUINOXE REVERSE 46MM HUMERAL LINER +0 PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086730

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10