BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 17421514 · Received July 29, 2023

    Report

    Report Number
    1038671-2023-01810
    Event Type
    Injury
    Date Received
    July 29, 2023
    Date of Event
    May 14, 2023
    Report Date
    July 17, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS 3003008; REVERSE HUMERAL TRAY 3201005; REVERSE GLENOSPHERE 3200642; REVERSE GLENOSPHERE BASEPLATE 3201501.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D4, G4, H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E. G THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REVISION REPORTED CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE DUE TO SOFT TISSUE IMBALANCE, PATIENT ANATOMY, IMPLANT POSITIONING, AND/OR IMPLANT SELECTION. DISLOCATION IS A KNOWN RISK, AS OUTLINED IN THE IFU. 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 60 YO MALE PATIENT EXPERIENCED A FAILED POLYETHYLENE COMPONENT. THE PATIENT DESCRIBED A POP IN RIGHT SHOULDER WHILE DOING SOME "TINKERING". FAILED RTSA; FIST ASSOCIATED POLY FROM PROXIMAL HUMERUS. THE DATE OF EVENT ONSET IS (B)(6) 2023. THE PATIENT WAS REVISED ON (B)(6) 2023. THE OUTCOME WAS LAST KNOWN AS RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2316982 EQUINOXE PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention| O SEE H10.