BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 18691182 · Received February 12, 2024

    Report

    Report Number
    1038671-2024-00202
    Event Type
    Injury
    Date Received
    February 12, 2024
    Date of Event
    November 22, 2022
    Report Date
    August 5, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    HSD
    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: 7075775 300-30-06 - EQUINOXE PRESERVE STEM 6MM; A157773 300-10-45 - EQUINOXE REPLICATOR PLATE 4.5MM O/S; A182574 314-23-02 - LASER CAGE GLENOID SMALL, ALPHA. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6 . MDR SECTION CODES UPDATED/CORRECTED: 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 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

    IT WAS REPORTED VIA A CLINICAL STUDY, ¿EQUINOXE SHOULDER STUDY¿, THAT A 38 YO FEMALE PATIENT, WHO HAD AN INITIAL TOTAL SHOULDER IMPLANTED ON (B)(6) 2022, WAS FIXED INTRAOPERATIVELY FOR A HUMERAL CALCAR FX FROM A PREVIOUS HARDWARE REMOVAL INTRA-OP. 3 SMALL 3.5MM HEADLESS SCREW COMPRESSION SCREWS WERE REMOVED. AUTOGRAFT BONE GRAFT WAS USED BEHIND THE BASEPLATE. THE EVENT WAS DEFINITELY NOT RELATED TO THE DEVICE, BUT DEFINITELY RELATED TO THE PROCEDURE. THE CLINICAL STUDY INDICATES THE EVENT WAS RESOLVED ON (B)(6) 2022. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    804985 EQUINOXE PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED HSD EXACTECH, INC. EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA) UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Female Required Intervention SEE H10