BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20895179 · Received December 10, 2024

    Report

    Report Number
    1038671-2024-04747
    Event Type
    Injury
    Date Received
    December 10, 2024
    Date of Event
    November 18, 2024
    Report Date
    May 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EXACTECH COMPLAINT HISTORY FROM JANUARY 1, 2008-OCTOBER 1, 2024 WAS REVIEWED FOR REPORTS OF SHOULDER INFECTIONS. THE SALES DATA FOR ALL HUMERAL STEMS WAS USED TO CALCULATE A COMPLAINT OCCURRENCE RATE OF <0.5%. THIS IS CONSIDERED ¿VERY LOW¿ ACCORDING TO THE FREQUENCY OF OCCURRENCE RANKING SCALE. A REVIEW OF THE STERILE CERTIFICATES AND/OR THE FINAL ENDOTOXIN TEST REPORTS WAS PERFORMED. ALL LOTS WERE ACCEPTED TO THE REQUIREMENTS. THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: D10. D10: 320-42-13 - 145-DEG PE 42MM CONST HUM LINER +2.5 (B)(6). 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE (B)(6). EXC-EQRV42-US - ORTHOSENSOR 42MM USA (B)(6). 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM (B)(6). 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM (B)(6). 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM (B)(6). 320-15-04 - RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT (B)(6). 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT (B)(6). 320-06-42 - GLENOSPHERE 42MM (B)(6). 315-35-00 - GLND KWIRE (B)(6). 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM (B)(6). 320-15-05 - EQ REV LOCKING SCREW (B)(6). 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 (B)(6). 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT (B)(6). TPA-13 - CEMENT RESTRICTOR XS (EXTRA SMALL, SZ 13) (B)(6). 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM (B)(6). 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM (B)(6).

    Additional Manufacturer Narrative · 0

    THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YEARS AFTER THE FIRST REVISION SURGERY, THE PATIENT UNDERWENT A SECOND RIGHT SIDE REVISION DUE TO INFECTION. THE PATIENT WAS REVISED TO AN ANTIBIOTIC SPACER. THERE WAS NO REPORTED BREAKAGE OF A DEVICE. THERE WAS A > 45 MINUTE DELAY, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS AS A RESULT. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1634226 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization SEE H11| SEE H11