BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 21358599 · Received February 11, 2025

    Report

    Report Number
    1038671-2025-00828
    Event Type
    Injury
    Date Received
    February 11, 2025
    Date of Event
    August 9, 2016
    Report Date
    February 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 300-01-13 - EQ, HUMERAL STEM PRIMARY, PRESS FIT 13MM: 4259111; 320-46-00 - EQUINOXE REV 46MM HUMERAL LINER +0: 3582466; 320-10-00 - EQUINOXE REV TRAY ADAPTER PLATE TRAY +0: 4261255; 320-01-46 - EQUINOXE REV 46MM GLENOSPHERE: 2646032; 320-15-01 - EQ REV GLENOID PLATE: 4211947. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A STANDARD REVERSE REVISION, APPROXIMATELY 5 MONTHS POST OPERATIVELY OF THE INITIAL IMPLANTATION OF DEVICES FOR UNKNOWN REASONS. THIS WAS FOLLOWING A TENDON TRANSFER WITH ROTATOR CUFF REPAIR 3 MONTHS POST OPERATIVELY FOR UNKNOWN REASONS (SEE (B)(4)). THE OUTCOME OF THIS EVENT IS UNKNOWN. THIS WAS REPORTED THROUGH CLINICAL TRIAL STUDY DATA COLLECTION ACTIVITIES, NO DEVICE RETURN IS ANTICIPATED, AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1043262 EQUINOXE REVERSE SHOULDER COMPONENTS SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Male Hospitalization SEE H11.