BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE CAGE GLENOID M, POST AUG, RIGHT

    MDR report key: 17474676 · Received August 7, 2023

    Report

    Report Number
    1038671-2023-01885
    Event Type
    Injury
    Date Received
    August 7, 2023
    Date of Event
    June 27, 2023
    Report Date
    September 26, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWS
    UDI-DI
    10885862201010
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3000111; HUMERAL HEAD 3100147; REPLICATOR PLATE 3001015.

    Additional Manufacturer Narrative · 0

    (H3) THE POTENTIAL REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BONE BETWEEN THE IMPLANT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) GLENOID LOOSENING. THE EXTENT AND ROOT CAUSE OF THE GLENOID LOOSENING COULD NOT BE DETERMINED AS THE DEVICE, NOR IMAGES OF THE DEVICE, COULD NOT BE RETURNED, AND RADIOGRAPHS WERE NOT PROVIDED. THE MOST PROBABLE ROOT CAUSE ASSOCIATED WITH THE EVENT OF ¿LOOSENING - GLENOID¿ IS ASSOCIATED WITH WEAKENED INTEGRATION OF THE DEVICE AT THE BONE-IMPLANT INTERFACE DUE TO LOSS OF FIBROUS AND/OR BONY TISSUE AND LEADING TO COMPROMISED ANCHORAGE OF THE DEVICE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 6 YEARS POSTOP THE INITIAL IMPLANT, THIS 68 YO MALE PATIENT WAS REVISED DUE TO ASEPTIC GLENOID LOOSENING CONFIRMED BY X-RAY. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DEVICES WILL NOT BE RETURNED.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 6 YEARS POSTOP THE INITIAL IMPLANT, THIS PATIENT WILL BE REVISED (B)(6) 2023 DUE TO ASEPTIC GLENOID LOOSENING CONFIRMED BY X-RAY. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. DEVICES WILL NOT BE RETURNED. NEW INFORMATION RECEIVED (B)(6) 2024 INDICATES THE PATIENT ULTIMATELY DID NOT DECIDE ON SURGERY AND THE OUTCOME OF THIS EVENT IS NOW CONSIDERED RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1337366 EQUINOXE CAGE GLENOID M, POST AUG, RIGHT PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWS EXACTECH, INC. EQUINOXE CAGE GLENOID M, POST AUG, RIGHT 4269822 10885862201010

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Other| R SEE H10.| SEE H11.