BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMALL SUPERIOR AUGMENT GLENOID PLATE

    MDR report key: 18882197 · Received March 11, 2024

    Report

    Report Number
    1038671-2024-00461
    Event Type
    Injury
    Date Received
    March 11, 2024
    Date of Event
    February 12, 2024
    Report Date
    August 1, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    UDI-DI
    10885862534873
    PMA / PMN Number
    K180632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: A699725 - 304-21-09 - 8.5MM PLATFORM FX STEM LEFT A496893 - 315-35-00 - GLND KWIRE 6898149 - 320-00-01 - 0 STD LEFT TRAY A791585 - 320-15-05 - EQ REV LOCKING SCREW A592211 - 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT S336580 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S437460 - 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM S375722 - 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM A746504 - 320-35-02 - SMALL SUPERIOR AUGMENT GLENOID PLATE A589552 - 320-36-00 - 145-DEG PE 36MM HUM LINER +0 A826863 - 531-78-20 - SHOULDR GPS HEX PINS KIT ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    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, D4, H4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REVISION REPORTED WAS LIKELY DUE TO A BONE FRACTURE. THE REASON FOR THE FRACTURE 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. 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

    IT WAS REPORTED A FEMALE PATIENT, INITIAL LEFT SHOULDER IMPLANTED ON (B)(6) 2024, UNDERWENT A REVISION PROCEDURE ON (B)(6), 2024. THE PATIENT FRACTURED HER GLENOID. NO FALL OR ACCIDENT OCCURRED. THE SURGEON REMOVED THE BASEPLATE, HAT, RECONSTRUCTED THE GLENOID, AND IMPLANTED A COMPETITOR¿S BASEPLATE AND EXACTECH TRAY AND LINER TO MATCH. THERE WERE NO SURGICAL DELAYS OR DEVICE BREAKAGES DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. AN X-RAY WAS PROVIDED. THE EXPLANTED DEVICES ARE NOT AVAILABLE FOR ANALYSIS. THE SURGEON KEPT THEM. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2451003 SMALL SUPERIOR AUGMENT GLENOID PLATE SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC. GLENOSPHERE, 36MM UNK 10885862534873

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention SEE H10.