BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 20547244 · Received October 28, 2024

    Report

    Report Number
    1038671-2024-04141
    Event Type
    Injury
    Date Received
    October 28, 2024
    Date of Event
    June 3, 2015
    Report Date
    February 18, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): STAGE 1 (SPACER): SPS0121K - SM. SPACER SHOULDER KIT 41MM AA7842040. STAGE 2 (REVISION): 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM: 3789863, 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0: 3925407, 320-42-00 - EQUINOXE REVERSE 42MM HUMERAL LINER +0: 3972939, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 3961703, 320-01-42 - EQUINOXE REVERSE 42MM GLENOSPHERE: 3977971, 320-15-05 - EQ REV LOCKING SCREW: 3971959, 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE: 3813145.

    Description of Event or Problem · 0

    APPROXIMATELY 8 MONTH(S) AND 2 DAY(S) POST-OPERATIVE OF A RIGHT RTSA, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED INFECTION. SUBJECT HAD INFECTED TSA DONE ELSEWHERE AND PERFORMED A TWO-STAGE REVISION. SUBJECT IS NOW INFECTED AGAIN. THE PATIENT UNDERWENT FIRST STAGE OF A STANDARD TOTAL REVISION WITH THE IMPLANTATION OF AN ANTIBIOTIC SPACER. APPROXIMATELY 4 YEAR(S), 6 MONTH(S) AND 15 DAY(S) FOLLOWING, THE SECOND STAGE OF THE REVISION WAS COMPLETED WITH THE REPORTED REMOVAL OF THE HUMERAL TRAY, HUMERAL LINER, GLENOSPHERE, GLENOSHPERE LOCKING SCREW, GLENOID BASE PLATE, AND COMPRESSION SCREW / LOCKING CAP. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE(S) AND/OR TO THE PROCEDURE. THIS EVENT WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1167949 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention SEE H11