BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ REV GLENOID PLATE

    MDR report key: 20402089 · Received October 8, 2024

    Report

    Report Number
    1038671-2024-03868
    Event Type
    Injury
    Date Received
    October 8, 2024
    Date of Event
    September 30, 2020
    Report Date
    April 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086488
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN DUE TO GLENOID OR SCREW LOOSENING. HOWEVER, THE REPORTED GLENOID LOOSENING COULD NOT BE CONFIRMED. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    (D10): CONCOMITANT DEVICE(S): 300-01-15 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM: 5800029 IMPLANT DATE: ON (B)(6) 2019). 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 6152915. 320-15-01 - EQ REV GLENOID PLATE: 6174681. 320-15-05 - EQ REV LOCKING SCREW: 6152475. 320-38-00 - EQUINOXE REVERSE 38MM HUMERAL LINER +0: 6151762.

    Description of Event or Problem · 0

    APPROXIMATELY 11 MONTH(S) AND 21 DAY(S) POST-OPERATIVE OF A PREVIOUSLY REVISED LEFT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED ASEPTIC GLENOID LOOSENING. X-RAYS SHOWED A LOOSE GLENOID SCREW, AND FURTHER IMAGING SHOWED LOOSENING OF THE GLENOID. THE PREVIOUS REVISION WAS DUE TO A SUBSCAPULARIS TEAR OF THE ROTATOR CUFF. THE PATIENT UNDERWENT A STANDARD REVERSE REVISION WITH THE REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE AND GLENOID BASE PLATE. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED AND THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21975 EQ REV GLENOID PLATE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086488

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention SEE H11