BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID L, POST AUG, LEFT

    MDR report key: 19209072 · Received April 29, 2024

    Report

    Report Number
    1038671-2024-01008
    Event Type
    Injury
    Date Received
    April 29, 2024
    Date of Event
    April 8, 2024
    Report Date
    April 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862200983
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: 4430522 310-01-50 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA). 4771083 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. 4838568 300-01-12 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 12MM. 4870014 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. 4875970 315-35-00 - GLND KWIRE. 4906933 315-35-00 - GLND KWIRE. 4918874 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 REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY HAVE BEEN DUE TO AN INSUFFICIENT BOND BETWEEN THE GLENOID COMPONENT AND THE BONE AND/OR THE HUMERAL STEM AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) ANATOMIC GLENOID LOOSENING AND/OR HUMERAL LOOSENING RESPECTIVELY. 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 LEGAL DOCUMENTATION THAT A PATIENT HAD A RIGHT TOTAL SHOULDER REPLACEMENT PROCEDURE ON (B)(6) 2017 AND THEN WAS REVISED ON (B)(6) 2024. PATIENT REQUIRED REVISION SURGERY FOR ISSUES INCLUDING BUT NOT LIMITED TO COMPONENT LOOSENING. BOTH THE HUMERAL STEM AND ANATOMIC CAGE GLENOID COMPONENTS WERE LOOSE. THE COMPONENTS WERE REMOVED AND THE SURGEON IMPLANTED COMPETITOR IMPLANTS. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1022827 EQUINOXE CAGE GLENOID L, POST AUG, LEFT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862200983

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention SEE H10