BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20630558 · Received November 7, 2024

    Report

    Report Number
    1038671-2024-04289
    Event Type
    Injury
    Date Received
    November 7, 2024
    Date of Event
    October 22, 2024
    Report Date
    January 10, 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

    PENDING INVESTIGATION. D10: A757773 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM A901294 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE A924807 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6583373 320-15-01 - EQ REV GLENOID PLATE A862668 320-15-05 - EQ REV LOCKING SCREW A706919 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT A824314 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM S427500 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM S514078 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM S496699 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM S390087 320-42-03 - EQUINOXE REVERSE 42MM HUMERAL LINER +2.5 A464505 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT A781936 321-52-09 - 3.2MM K-WIRE, TROCAR TIP.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. G4: 510K 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 AN UNDERLYING PATIENT CONDITION AND/OR THE SURGICAL PROCEDURE. 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

    AS REPORTED, THE PATIENT PRESENTED WITH INFECTION OF THEIR RIGHT TOTAL SHOULDER ARTHROPLASTY (TSA). APPROXIMATELY SIX MONTHS AND SIX DAYS POST THE INITIAL TSA, THE EQUINOXE REVERSE WAS TAKEN OUT AND AN ANTIBIOTIC SPACER WAS PUT BACK IN. 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
    1598309 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Required Intervention| H SEE H11