BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID MEDIUM, BETA

    MDR report key: 23111671 · Received September 22, 2025

    Report

    Report Number
    1038671-2025-02958
    Event Type
    Injury
    Date Received
    September 22, 2025
    Date of Event
    September 3, 2025
    Report Date
    October 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    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/CORRECTED: D1, G3, H6, H11. MDR SECTION CODES UPDATED/CORRECTED: B, C, D. THE REVISION WAS LIKELY THE RESULT OF SEVERE PROSTHESIS WEAR OF THE GLENOID COMPONENT AFTER UNEVEN LOADING AND/OR INCLUSION OF THE POLYETHYLENE COMPONENT IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS FROM USER OR PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION. 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

    D10: 4190106 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM 4346330 300-21-00 - 0MM FIXED ANGLED KIT 4304723 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA) SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 78 YO FEMALE PATIENT, WHO HAD A RIGHT SHOULDER IMPLANTED, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 9 YEARS 4 MONTHS POST THE INITIAL PROCEDURE. THE SURGEON BELIEVED THAT PATIENT HAD SUFFERED A FALL WHICH LED TO A PROXIMAL HUMERAL PERI-PROSTHETIC FRACTURE. THE PATIENT HAD LOTS OF PAIN IN HER SHOULDER AND WAS SEEN BY A PROVIDER. SUBSEQUENTLY A REVISION OCCURRED. THE HUMERAL HEAD, REPLICATOR PLATE, TORQUE SCREW, AND GLENOID WERE EXPLANTED. SOME ¿PRETTY ADVANCED WEAR¿ ON THE ANTERIOR EDGE OF THE POLY WAS INDICATED. THE HUMERAL STEM WAS WELL FIXED, AND THE PATIENT WAS REVISED TO A REVERSE TSA. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN AS THE HOSPITAL DOES NOT RELEASE THEM. A DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1959845 EQUINOXE CAGE GLENOID MEDIUM, BETA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Female Required Intervention SEE H11.