BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER SYSTEM

    MDR report key: 19629587 · Received June 27, 2024

    Report

    Report Number
    1038671-2024-02187
    Event Type
    Injury
    Date Received
    June 27, 2024
    Date of Event
    March 28, 2023
    Report Date
    July 10, 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

    (D10) CONCOMITANTS: 320-42-00 - 145-DEG PE 42MM HUM LINER +0: S341547. 300-01-13 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM: 7160436. 300-01-14 - EQUINOXE HUMERAL STEM PRIMARY PRESS FIT 14MM: 7156005. 320-06-42 - GLENOSPHERE 42MM: 6989668. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 7103552. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: 7280542. 531-78-20 - SHOULDR GPS HEX PINS KIT: 7263558. 320-15-05 - EQ REV LOCKING SCREW: 6651386. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 7267995. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 7294136. 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: S351455. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: S350001. 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: S344374. 321-52-07 - 3.2MM DRILL BIT STERILE: 6562966. 321-52-07 - 3.2MM DRILL BIT STERILE: 6586561. A10012 - GPS IMPLANT KIT V2: 08000121265.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D1/D2A/D2B, D4, H4, G4, H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, F, G. PMA 510K CANNOT BE DETERMINED; DEVICE IS UNKNOWN. CATALOG NUMBER, UDI NUMBER, SERIAL NUMBER, EXPIRATION AND MANUFACTURED DATES UNKNOWN. NO EXPLANT DATE. THE CAUSE OF THE PATIENT¿S SHOULDER DISLOCATION AND SUBSEQUENT REDUCTION 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 APPROXIMATELY 11 MONTHS AND 20 DAYS AFTER A RIGHT TSA, THE PATIENT DISLOCATED HIS SHOULDER. PATIENT STATES THAT THIS MORNING THEY LEANED ON RIGHT ARM AND FELT SHOULDER SHIFT OUT OF PLACE. PATIENT NOTED 10/10 PAIN AND LACK OF ROM. THE PATIENT HAD AN IN OFFICE REDUCTION AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THIS ADVERSE EVENT WAS REPORTED TO NOT BE RELATED TO THE DEVICE OR PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    827775 EQUINOXE SHOULDER SYSTEM PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male SEE H11