BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE REVERSE SHOULDER COMPONENTS

    MDR report key: 17660502 · Received August 31, 2023

    Report

    Report Number
    1038671-2023-02109
    Event Type
    Injury
    Date Received
    August 31, 2023
    Date of Event
    May 29, 2023
    Report Date
    July 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. H10: 6967200 300-30-09 - EQUINOXE PRESERVE STEM 9MM. 7123903 320-06-42 - GLENOSPHERE 42MM. A010144 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 7297369 320-15-08 - SUP/POST AUG PLATE, R RS GLENOID BASEPLATE.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: B3, D1/D2A/D2B, D4, H6 MDR SECTION CODES UPDATED/CORRECTED: A, B, C, D, E, F, G PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. 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

    AS REPORTED, THE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2022. THE PATIENT PRESENTED ON (B)(6)2023 AND HAD A INITIAL DISLOCATION WHILE DRINKING THAT SPONTANEOUSLY REDUCED IN CAR. HAD PAIN/INSTABILITY SINCE AND DISLOCATED AGAIN ON (B)(6) 2023, UNABLE TO REDUCE IN ED. POLY DISASSOCIATION CONFIRMED BY CT. THE PATIENT WAS REVISED (B)(6) 2023. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO DEVICE, DEFINITELY RELATED TO PROCEDURE. OUTCOME: RESOLVED ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1261757 EQUINOXE REVERSE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

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