BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE SHOULDER COMPONENTS

    MDR report key: 18762914 · Received February 22, 2024

    Report

    Report Number
    1038671-2024-00303
    Event Type
    Injury
    Date Received
    February 22, 2024
    Date of Event
    February 12, 2019
    Report Date
    August 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    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

    (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 320-01-46 - EQUINOXE REVERSE 46MM GLENOSPHERE: 5254937. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE: TRAY +0 5276430. 320-15-01 - EQ REV GLENOID PLATE: 5275661. 320-15-05 - EQ REV LOCKING SCREW: 5244068. 320-20-00 - EQ REVERSE TORQUE DEFINING SCREW KIT: 5224163. 320-20-22 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 22MM: 5238127. 320-20-30 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM: 5223834. 320-20-38 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM: 3908065. 320-46-00 - EQUINOXE REVERSE 46MM HUMERAL LINER +0: 4447907. 321-20-00 - EQUINOXE REVERSE SHOULDER DRILL KIT: 5263226.

    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, D4, 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. THE REASON FOR THE PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED BUT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT 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 82-YEAR-OLD FEMALE PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2018 AND PRESENTED WITH PAIN-UNEXPLAINED FROM A FALL, 1 YEAR(S) AND 0 MONTH(S) POST INITIAL PROCEDURE ON (B)(6) 2019. THE OUTCOME OF THIS EVENT IS CONSIDERED UNKNOWN AND THE ACTION TAKEN WAS CT SCAN ORDERED. THE CASE REPORT FORM INDICATES THAT THIS EVENT IS POSSIBLY RELATED TO THE DEVICE AND UNLIKELY RELATED 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
    130706 EQUINOXE SHOULDER COMPONENTS PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Male SEE H10