BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID S, POST AUG, RIGHT

    MDR report key: 15789671 · Received November 14, 2022

    Report

    Report Number
    1038671-2022-01458
    Event Type
    Injury
    Date Received
    November 14, 2022
    Date of Event
    October 25, 2022
    Report Date
    October 16, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862201003
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 5789123, 300-01-11 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM; 5150165, 300-51-15 - 1.5 SHORT FA REP PLT KIT; 5148477, 310-01-44 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA); 5816704, 315-35-00 - GLND KWIRE; 5546691, 531-78-20 - SHOULDR GPS HEX PINS KIT. 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 60 YO FEMALE, INITIAL RIGHT SHOULDER IMPLANTED (B)(6) 2019, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 3 YEARS 8 MONTHS POST THE INITIAL PROCEDURE. PER THE SURGEON, "THE GLENOID FAILED" AND OCCURRED OVER TIME. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE PRODUCT IS NOT RETURNING DUE TO HOSPITAL POLICY. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1861357 EQUINOXE CAGE GLENOID S, POST AUG, RIGHT PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. EQUINOXE CAGE GLENOID S, POST AUG, RIGHT UNK 10885862201003

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Female Required Intervention