BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20248693 · Received September 18, 2024

    Report

    Report Number
    1038671-2024-03596
    Event Type
    Injury
    Date Received
    September 18, 2024
    Date of Event
    September 10, 2024
    Report Date
    December 13, 2024
    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. THE FOLLOWING SECTIONS WERE UPDATED: G4: 510K UNKNOWN DUE TO SPECIFIC DEVICE NOT BEING REPORTED H6. THE FOLLOWING SECTIONS WERE CORRECTED: B2. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED. 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

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 7121172, 300-30-08 - EQUINOXE PRESERVE STEM 8MM. A646028, 315-35-00 - GLND KWIRE. A595312, 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE. A611123, 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5. A600541, 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG. A608993, 320-15-05 - EQ REV LOCKING SCREW. A534545, 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. A569345, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S457700, 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S456165, 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM. A557634, 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. A613320, 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0. A482013, 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE. A587779, 531-78-20 - SHOULDR GPS HEX PINS KIT. A588407, 531-78-20 - SHOULDR GPS HEX PINS KIT. 02016823125, A10012 - GPS IMPLANT KIT V2.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 62 Y/O MALE PATIENT'S SHOULDER WAS REVISED APPROXIMATELY 6 MONTHS POST OP. HE GREW A BUG IN THE PATHOLOGY LAB AND SURGEON ELECTED TO REMOVE ALL IMPLANTS AND RE IMPLANT A COMPETITORS SHOULDER. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1360802 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention| H SEE H11.