BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL GLENOID PLATE

    MDR report key: 19093927 · Received April 11, 2024

    Report

    Report Number
    1038671-2024-00810
    Event Type
    Injury
    Date Received
    April 11, 2024
    Date of Event
    December 4, 2023
    Report Date
    May 20, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    UDI-DI
    10885862534866
    PMA / PMN Number
    K180632
    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): 320-36-03 - 36MM HUMERAL LINER +2.5MM UNCONSTRAINED : 7031167. 320-36-03 - 145-DEG PE 36MM HUM LINER +2.5 : 7049043. 320-31-36 - GLENOSPHERE, 36MM : 7091874. 300-30-06 - EQUINOXE PRESERVE STEM 6MM : 6741380. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 : 7066306. 315-35-00 - GLND KWIRE : 7015677. 320-15-05 - EQ REV LOCKING SCREW : 7096590. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT : 7005798. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM : S297627. 320-20-26 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM : S279420. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM : S243691. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM : S276888. (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE PAIN AND SUBSEQUENT REVISION REPORTED MAY BE DUE TO ASEPTIC GLENOID AND HUMERAL LOOSENING RESULTING FROM A FALL AS REPORTED. HOWEVER, THESE FAILURES CANNOT BE CONFIRMED AS NO RELEVANT CLINICAL INFORMATION, IMAGES, OR RADIOGRAPHS WERE PROVIDED. POTENTIAL CONTRIBUTIONS OF PATIENT OR USER-RELATED ISSUES TO THE EVENT CANNOT BE DETERMINED FROM THE REPORTED INFORMATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THE 70-YEAR-OLD WHITE FEMALE HAD A RIGHT TSA ON (B)(6) 2021. ON (B)(6) 2023, THE PATIENT EXPERIENCE ASEPTIC GLENOID LOOSENING. FELL POSTOP AND STARTED TO DEVELOP PAIN OVER TIME WITH GLENOID/HUMERAL LOOSENING PRESENT ON (B)(6) 2023 XR; NO BACTERIA GROWTH SO LIKELY ASEPTIC LOOSENING. THE PATIENT UNDERWENT THE ACTION OF STANDARD REVERSE W-PRESERVE STEM REVISION SURGERY ON (B)(6) 2024. THE PATIENT WAS REVISED TO NON-EXACTECH SPACER AND THE OUTCOME OF THIS EVENT IS CONSIDERED TO BE RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED 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
    837945 SMALL GLENOID PLATE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC. 10885862534866

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female SEE H10