BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID SMALL, ALPHA

    MDR report key: 18467608 · Received January 8, 2024

    Report

    Report Number
    1038671-2024-00038
    Event Type
    Injury
    Date Received
    January 8, 2024
    Date of Event
    October 26, 2021
    Report Date
    May 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862172679
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 300-30-06 - EQUINOXE PRESERVE STEM 6MM: 5094102 310-01-41 - EQUINOXE, HUMERAL HEAD SHORT, 41MM (ALPHA): 5113361 300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S: 5115328.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE PAIN REPORTED IN MAY BE THE RESULT OF THE GLENOID LOOSENING AS REPORTED. HOWEVER, THE FAILURE CANNOT BE CONFIRMED AS NO RELEVANT CLINICAL INFORMATION, IMAGES, OR RADIOGRAPHS WERE PROVIDED. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, PATIENT, OR USER-RELATED ISSUES TO THE EVENT CANNOT BE DETERMINED FROM THE REPORTED INFORMATION. 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

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE PATIENT HAD AN INITIAL LEFT TSA ON (B)(6) 2018. THE PATIENT PRESENTED ON (B)(6) 2021 WITH ASEPTIC GLENOID LOOSENING. PATIENT HAS BEEN HAVING INCREASING LEFT SHOULDER PAIN. X-RAYS SHOW GLENOID COMPONENT LOOSENING. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE AND/ TO PROCEDURE. OUTCOME IS RESOLVED BY REVISION ON (B)(6) 2021. NO DEVICE RETURN ANTICIPATED DUE TO BEING A CLINICAL TRIAL STUDY. EBI INITIAL SURGERY ATTACHED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568464 EQUINOXE CAGE GLENOID SMALL, ALPHA PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. 10885862172679

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Male SEE H10