BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID LARGE, BETA

    MDR report key: 18803637 · Received February 28, 2024

    Report

    Report Number
    1038671-2024-00336
    Event Type
    Injury
    Date Received
    February 28, 2024
    Date of Event
    January 26, 2024
    Report Date
    March 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862172716
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE MIGRATION AND INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. D1: CORRECTED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 2532751-310-01-53 - EQUINOXE, HUMERAL HEAD SHORT, 53MM (BETA). 2719489-300-01-15 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM. 2770139-314-13-14 - EQUINOXE CAGE GLENOID LARGE, BETA. 2840008-300-10-15 - EQUINOXE REPLICATOR PLATE 1.5MM O/S. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT, INITIAL RIGHT SHOULDER IMPLANTED ON (B)(6)2014, UNDERWENT A REVISION PROCEDURE ON (B)(6)2024, APPROXIMATELY 9 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT PRESENTED WITH COMPLAINTS OF PAIN. THE GLENOID COMPONENT HAD MIGRATED FROM ITS ORIGINAL POSITION. SIGNIFICANT WEAR AND OSTEOLYSIS FOUND. BONE GRAFTING AND CONVERSION TO REVERSE WAS PERFORMED. THERE WERE NO ISSUES WITH THE SURGERY. X-RAYS WERE PROVIDED. EXPLANTED DEVICES ARE NOT AVAILABLE FOR RETURN. DEVICE IMAGES WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497989 EQUINOXE CAGE GLENOID LARGE, BETA PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. EQUINOXE CAGE GLENOID LARGE, BETA UNK 10885862172716

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10