BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20347709 · Received October 1, 2024

    Report

    Report Number
    1038671-2024-03779
    Event Type
    Injury
    Date Received
    October 1, 2024
    Date of Event
    August 10, 2024
    Report Date
    January 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, MAY HAVE RESULTED FROM 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.

    Additional Manufacturer Narrative · 0

    (D10): CONCOMITANT DEVICE(S): 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM: 6793911, 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE: 6917886, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 6879453, 320-15-03 - RS GLENOID PLATE L POST AUG, 8 DEG, LEFT: 6764926, 320-15-05 - EQ REV LOCKING SCREW: 6651849, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 6913682, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: S261032, 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: S263337, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 6221048, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: S262703, 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0: S253752.

    Description of Event or Problem · 0

    APPROXIMATELY, 3 YEARS, 1 MONTH, 25 DAYS POST-OPERATIVE OF A LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ANOTHER DISLOCATION WITH 3 NEW DISLOCATIONS IN 2024 AND REQUIRES REVISION OF THE PROSTHESIS. PREVIOUSLY REPORTED ON CASE: (B)(4), THE PATIENT HAD EXPERIENCED INSTABILITY AND A DISLOCATION THAT WAS REDUCED IN THE HOSPITAL WITH ADDITIONAL IMMOBILIZATION IN A SLING FOR 3 WEEKS GENTLE REHABILITATION AFTER IMMOBILIZATION. THE PATIENT UNDERWENT STANDARD REVERSE REVISION WITH THE REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, AND GLENOSPHERE LOCKING SCREW COMPONENTS. 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
    1915362 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Required Intervention SEE H11.