BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 17549485 · Received August 15, 2023

    Report

    Report Number
    1038671-2023-01951
    Event Type
    Injury
    Date Received
    August 15, 2023
    Date of Event
    July 13, 2023
    Report Date
    July 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 5747666 300-30-08 - EQUINOXE PRESERVE STEM 8MM 6116393 320-01-38 - EQUINOXE REVERSE 38MM GLENOSPHERE 6159671 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 6023749 320-15-05 - EQ REV LOCKING SCREW 5572363 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE 6013749 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT 5366995 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 5358877 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM 5818495 320-20-42 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM 6156083 531-20-00 - SHLDR GPS RVRS DRILL KIT 6070237 531-78-20 - SHOULDR GPS HEX PINS KIT 6000019241 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/CORRECTED: D1, D4, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E. THE REASON FOR THE PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION, INFECTION, COMPONENT LOOSENING, COMPONENT SIZING, POSITIONING, OR IMPINGEMENT ISSUES, OR A COMBINATION OF THE ABOVE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. 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 4 YEARS POST OP INITIAL RIGHT TSA, THIS 67 Y/O FEMALE PATIENT WAS REVISED DUE TO PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS, UNABLE TO OBTAIN. IMAGE ATTACHED. NO PRODUCT RETURN; HOSPITAL POLICY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    962704 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female