BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN SHOULDER COMPONENTS

    MDR report key: 20502591 · Received October 22, 2024

    Report

    Report Number
    1038671-2024-04065
    Event Type
    Injury
    Date Received
    October 22, 2024
    Date of Event
    October 3, 2024
    Report Date
    September 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 6778419 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S. 5740093 300-30-09 - EQUINOXE PRESERVE STEM 9MM. 6765450 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA). 5448296 314-13-14 - EQUINOXE CAGE GLENOID LARGE, BETA. 6480069 315-35-00 - GLND KWIRE. 7070464 531-78-20 - SHOULDR GPS HEX PINS KIT. 6811881 300-20-02 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT.

    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, G. THE REVISION WAS LIKELY THE RESULT OF ROTATOR CUFF DETERIORATION AND SUBSEQUENT SUPERIOR MIGRATION OF THE HUMERAL HEAD RESULTING IN PROSTHESIS WEAR OF THE GLENOID COMPONENT. THE REASON FOR THE ROTATOR CUFF FAILURE CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION, COMPONENT SIZING OR POSITIONING ISSUES, OR A COMBINATION OF THE ABOVE. 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 THAT THIS PATIENT'S RIGHT SHOULDER WAS REVISED 3 YEARS POST OP. PATIENT HAD A ROTATOR CUFF FAILURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2344853 UNKNOWN SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Male Required Intervention SEE H11.