BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20306251 · Received September 25, 2024

    Report

    Report Number
    1038671-2024-03712
    Event Type
    Injury
    Date Received
    September 25, 2024
    Date of Event
    September 5, 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

    PENDING INVESTIGATION. D10: A887055 300-30-08 - EQUINOXE PRESERVE STEM 8MM; B073246 320-02-38 - RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET; B045722 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0; A947850 320-15-02 - RS GLENOID PLATE SUP AUG, 10 DEG; A981503 320-15-05 - EQ REV LOCKING SCREW; B114399 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT; A061665 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; S524015 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM; S523513 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM; A434284 320-38-10 - EQUINOXE REVERSE 38MM HUMERAL CONST LINER +0; A290161 321-52-10 - 3.2MM K-WIRE, THD, SHORT 2 K-WIRES PER PACK; A995689 531-55-88 - ERGO GPS 3.2MM DRILL KIT STERILE; B003614 531-78-20 - SHOULDR GPS HEX PINS KIT; 12000723121 A10012 - GPS IMPLANT KIT V2.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D8. 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.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 1 WEEK AND 3 DAYS POST THE INITIAL LEFT TSA, THE PATIENT WAS REVISED DUE TO A SUSPECTED WOUND INFECTION. A NEW PRESERVE STEM, ADAPTER TRAY, LINER AND GLENOSPHERE WERE IMPLANTED. 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
    1198289 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Male Required Intervention| H SEE H11.