BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 19122304 · Received April 16, 2024

    Report

    Report Number
    1038671-2024-00875
    Event Type
    Injury
    Date Received
    April 16, 2024
    Date of Event
    June 3, 2021
    Report Date
    July 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 6389934 - 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5. 6535125 - 320-15-07 - SUP/POST AUG PLATE, L RS GLENOID BASEPLATE. 6539212 - 321-52-07 - 3.2MM DRILL BIT STERILE. 6539724 - 320-15-06 - RS GLENOID PLATE EXT CAG +10MM CAGE PEG. 6544562 - 321-52-09 - 3.2MM K-WIRE, TROCAR TIP. 6614881 - 300-01-10 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 10MM. 6687160 = 320-06-38 - GLENOSPHERE 38MM. 6748235 - 315-35-00 - GLND KWIRE. 6761488 - 315-35-00 - GLND KWIRE. 6804424 - 320-15-05 - EQ REV LOCKING SCREW. 6807822 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT. S120682 - 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM. S123681 - 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. S200725 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM. S206822 - 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM. S212330 - 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM. S222254 - 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM.

    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, H6 . MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REASON FOR THE REPORTED REVISION DUE TO SUSPECTED INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION OR 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

    IT WAS REPORTED VIA A VOLUNTARY MEDWATCH REPORT #MW5152512 , THAT A MALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6), 2021, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2021, APPROXIMATELY 3 MONTHS POST THE INITIAL PROCEDURE. THE REPORTER CALLED TO REPORT PROBLEMS AFTER HER HUSBAND RECEIVED 2 EQUINOXE SHOULDER SYSTEM REPLACEMENTS, EACH FOR THE LEFT SHOULDER. THE REPORTER STATES HER HUSBAND HAD INITIAL SHOULDER REPLACEMENT SURGERY ON (B)(6) 2021, AND CAME DOWN WITH AN INFECTION ALMOST IMMEDIATELY AFTER IMPLANT. THE REPORTER STATED HER HUSBAND CONTINUALLY COMMUNICATED TO THE SURGEON HE WAS HAVING PAIN IN HIS SHOULDER AND THAT IT WASN¿T FEELING RIGHT, HOWEVER THE SURGEON DISMISSED THAT ANYTHING WAS WRONG. THE REPORTER STATED THAT THIS PROCESS CONTINUED FOR 2 MONTHS BEFORE THE SURGEON¿S OFFICE BELIEVED THAT THERE WAS AN INFECTION. THE REPORTER STATES THAT ON AN UNKNOWN DATE IN 2021, AS SHE WAS RUBBING PAIN-RELIEVING CREAM ON HER HUSBAND¿S SHOULDER, SHE NOTICED A ¿BRIGHT RED, PUFFY, SWOLLEN LUMP, ABOUT 3 INCH BY 3 INCH IN SIZE¿ ON HER HUSBAND¿S SHOULDER. SHE STATES A CT SCAN WAS PERFORMED ON AN UNKNOWN DATE IN 2021, WHICH SHOWED INFECTION. THE REPORTER STATES A ¿50CC SYRINGE¿ OF PUS WAS DRAINED FROM THIS LUMP, AND WHEN THE PHYSICIANS ASSISTANT APPLIED SLIGHT PRESSURE, PUS AND FLUID SQUIRTED OUT ON HER UNIFORM. SHE STATES SURGERY WAS PERFORMED ON (B)(6), 2021, AND ALL SHOULDER COMPONENTS WERE REMOVED EXCEPT FOR THE SHOULDER BALL, AND THE SHOULDER SITE WAS THOROUGHLY WASHED OUT BEFORE A NEW EQUINOXE DEVICE WAS AGAIN IMPLANTED. SHE STATES HER HUSBAND WAS PRESCRIBED DOXYCYCLINE AT THAT TIME AND CONTINUES WITH THAT PRESCRIPTION TODAY. THE REPORTER STATES THAT AFTER THIS REPLACEMENT SURGERY, HER HUSBAND CONTINUED TO EXPERIENCE PAIN AND LIMITED RANGE OF MOTION IN THE LEFT SHOULDER. NO FURTHER INFORMATION

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1340959 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male SEE H10