BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE HUMERAL LINER

    MDR report key: 20355780 · Received October 2, 2024

    Report

    Report Number
    1038671-2024-03796
    Event Type
    Injury
    Date Received
    October 2, 2024
    Date of Event
    January 28, 2019
    Report Date
    July 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10): CONCOMITANT DEVICE(S): 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0 5603524. 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM 5400693. 320-02-42 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET 5335122. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 5543515. 320-15-07 - SUP/POST AUG PLATE, L RS GLENOID BASEPLATE 5442434. 320-15-05 - EQ REV LOCKING SCREW 5499367. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 5589186. 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM 4329274. 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM 3838736. 320-20-46 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 46MM 5231424.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. 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 3 MONTHS AND 25 DAYS POST-OPERATIVE OF A LEFT TSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED DISLOCATION. PATIENT WAS MOVING BOXES AND DISLOCATED WHEN MOVING QUICKLY. THE PATIENT UNDERWENT STANDARD REVERSE REVISION WITH THE REMOVAL OF THE HUMERAL LINER AND GLENOSPHERE. ADDITIONALLY, THE PATIENT HAS BEEN NON-COMPLIANT WITH INSTRUCTIONS. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869855 EQUINOXE HUMERAL LINER PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention SEE H11.