BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20660163 · Received November 11, 2024

    Report

    Report Number
    1038671-2024-04348
    Event Type
    Injury
    Date Received
    November 11, 2024
    Date of Event
    October 15, 2024
    Report Date
    January 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. G4: 510K IS UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED. A REVIEW OF THE STERILE CERTIFICATES AND/OR FINAL ENDOTOXIN REPORTS WAS PERFORMED. THE STERILE LOTS WERE ACCEPTED WITH CONFORMANCE TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO AN INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO A PATIENT CONDITION. 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

    PENDING INVESTIGATION. D10: 304-21-07 - 6.5MM PLATFORM FX STEM LEFT 6791916, 320-38-10 - EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0 7229252, 315-35-00 - GLND KWIRE A058634, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM A141142, 531-20-00 - SHLDR GPS RVRS DRILL KIT A180178, 320-15-05 - EQ REV LOCKING SCREW A234886, 320-15-01 - EQ REV GLENOID PLATE A236741, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 A243329, 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE A243540, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A258137, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S260775, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM S350820, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S374772.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 YEAR AND 9 MONTHS POST THE INITIAL LEFT REVERSE TOTAL SHOULDER ARTHROPLASTY, THE PATIENT UNDERWENT A TWO STAGE REVISION DUE TO INFECTION. EVERYTHING WAS REMOVED AND A CEMENT SPACER WAS INSERTED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1514270 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention| H SEE H11