BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 21807223 · Received April 9, 2025

    Report

    Report Number
    1038671-2025-01781
    Event Type
    Injury
    Date Received
    April 9, 2025
    Date of Event
    November 18, 2024
    Report Date
    August 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-01-09 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM, 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED, 320-10-05 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5, 320-31-36 - GLENOSPHERE, 36MM, 320-35-01 - SMALL GLENOID PLATE. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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

    THE REASON FOR THE PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION, INFECTION, COMPONENT LOOSENING, COMPONENT SIZING, POSITIONING, OR IMPINGEMENT ISSUES, OR A COMBINATION OF THE ABOVE. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED. D1: CORRECTED. H6: CORRECTED INVESTIGATION CLINICAL CODES. H10: CORRECTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL SHOULDER REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED NERVE PAIN ASSOCIATED WITH PECTORALIS MINOR SYNDROME. AS A RESULT, APPROXIMATELY 1.5 YEARS AFTER INITIAL REPLACEMENT, THE PATIENT WAS ADMINISTERED AN INJECTION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1664272 SPECIFIC DEVICE NOT REPORTED SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Hospitalization SEE H11