BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRIMARY SHOULDER COMPONENTS

    MDR report key: 23251842 · Received October 9, 2025

    Report

    Report Number
    1038671-2025-03068
    Event Type
    Injury
    Date Received
    October 9, 2025
    Date of Event
    September 18, 2025
    Report Date
    October 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: A754679 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S. B013871 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. A994802 300-30-07 - EQUINOXE PRESERVE STEM 7MM. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D. THE REASON FOR THE SHOULDER SURGICAL REVISION REPORTED IN IS LIKELY DUE TO ROTATOR CUFF FAILURE AS REPORTED. CONTRIBUTIONS FROM PATIENT-RELATED ISSUES, SOFT TISSUE TENSIONING, AND/OR COMPONENT POSITIONING OR SIZING ISSUES TO THE REPORTED EVENT CANNOT BE DETERMINED FROM THE REPORTED INFORMATION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION WERE NOT PROVIDED. 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 67 YO MALE PATIENT, WHO HAD A RTSA, UNDERWENT A REVISION PROCEDURE APPROXIMATELY 1 YEAR 3 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. THEY HAD A HISTORY OF ARTHRITIS AND ¿NOT A GREAT CUFF¿. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS 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 DUE TO CHAIN OF COMMAND. EXPLANTED DEVICE IMAGE WAS PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2521807 EQUINOXE PRIMARY SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Required Intervention SEE H11.