BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQ REV GLENOID PLATE

    MDR report key: 18763222 · Received February 22, 2024

    Report

    Report Number
    1038671-2024-00305
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    February 9, 2020
    Report Date
    August 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086488
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM: 5710508. 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE: 5884751. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 5882520. 320-15-05 - EQ REV LOCKING SCREW: 5827971. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 5884259. 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: 5826540. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 5885855. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: 5771283. 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0: 5897736. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 5029152.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES. THE REASON FOR THE POST OPERATIVE BONE FRACTURE REPORTED IN CASE-(B)(4) CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO IMPLANT POSITIONING, PATIENT BONE QUALITY, A TRAUMA, AND/OR ANOTHER PATIENT RELATED CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 63-YEAR-OLD MALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6)2019 AND PRESENTED WITH ACROMIAL FRACTURE/STRESS FRACTURE, 0 YEAR(S) AND 11 MONTH(S) POST INITIAL PROCEDURE ON (B)(6)2020. THE OUTCOME OF THIS EVENT IS CONSIDERED UNKNOWN AND NO ACTION WAS TAKEN. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    260566 EQ REV GLENOID PLATE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. 10885862086488

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male SEE H10.