BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER SYSTEM

    MDR report key: 24340850 · Received February 14, 2026

    Report

    Report Number
    1038671-2026-00152
    Event Type
    Injury
    Date Received
    February 14, 2026
    Date of Event
    December 1, 2021
    Report Date
    February 14, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: HUMERAL STEM OR STEMLESS (CAT# 300-30-06). REVERSE HUMERAL TRAY (CAT# 320-10-00). REVERSE GLENOSPHERE (CA# 320-01-42). REVERSE GLENOSPHERE BASEPLATE (CAT# 320-15-01). H10: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2026-00151. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SHOULDER DISLOCATION AND INSTABILITY CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY [OBESE], OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. 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

    REPORT #2 OF 2 FOR THIS EVENT. AS REPORTED BY A CLINICAL STUDY, APPROXIMATELY TWO YEARS POST AN INITIAL RIGHT SIDE REVERSE TOTAL SHOULDER ARTHROPLASTY THE PATIENT EXPERIENCED INSTABILITY FOR ONE YEAR PRIOR TO A DISLOCATION. THE PATIENT REQUIRED PHYSICAL THERAPY. NO FURTHER PATIENT IMPACT WAS REPORTED. NO SURGICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. COULD NOT LOCATE INITIAL SURGERY IN EBI. 510K: K063569.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401509 EQUINOXE REVERSE SHOULDER SYSTEM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Male Other SEE H11.