BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE PRESERVE STEM 6MM

    MDR report key: 19182269 · Received April 25, 2024

    Report

    Report Number
    1038671-2024-00981
    Event Type
    Injury
    Date Received
    April 25, 2024
    Date of Event
    January 2, 2024
    Report Date
    August 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    PHX
    UDI-DI
    10885862515742
    PMA / PMN Number
    K162726
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 315-35-00 - GLND KWIRE: A496379, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0: A810307. 320-15-05 - EQ REV LOCKING SCREW: A498615. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: A757306. 320-20-18 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM: A805325. 320-20-34 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM: A813553. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: A804367. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: S478973. 320-31-36 - GLENOSPHERE, 36MM: A812120. 320-35-02 - SMALL SUPERIOR AUGMENT GLENOID PLATE: A711662. 320-36-00 - 145-DEG PE 36MM HUM LINER +0: A304550. 531-20-00 - SHLDR GPS RVRS DRILL KIT: A669039. 531-78-20 - SHOULDR GPS HEX PINS KIT: A622224. (H3) PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D6A, G4, H6 MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, F, G THE REASON FOR THE INTRAOPERATIVE BONE FRACTURE REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO A PATIENT CONDITION OR HIGH FORCES DURING BROACHING, REAMING, EXPOSURE, OR RETRACTION. HOWEVER, THIS CANNOT BE CONFIRMED BASED ON THE INFORMATION PROVIDED. 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 BY THE EQUINOXE SHOULDER STUDY, THE 59-YEAR-OLD NON-HISPANIC WHITE FEMALE HAD A RIGHT TSA (B)(6) 2024. THE PATIENT PRESENT WITH HUMERAL FRACTURE ¿ CALCAR, INTRA-OPERATIVELY ON (B)(6) 2024. THE ACTION OF CERCLAGE WAS TAKEN ON (B)(6) 2024 AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE AND/OR TO THE PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES AND NO DEVICE RETURN IS ANTICIPATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1614630 EQUINOXE PRESERVE STEM 6MM SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX EXACTECH, INC. 10885862515742

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female SEE H10.