BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12562519 · Received October 1, 2021

    Report

    Report Number
    1038671-2021-00504
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    September 13, 2021
    Report Date
    February 15, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF DETERIORATION OF THE BOND BETWEEN THE HUMERAL STEM AND THE BONE AFTER BEING IMPLANTED FOR OVER 10 YEARS, WHICH LED TO ASEPTIC (NON-INFECTED) HUMERAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION AND X-RAY IMAGES WERE NO PROVIDED. (D4) CATALOG NUMBER: 300-01-15, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 20-APR-2021, UNIQUE IDENTIFIER (UDI) #: (B)(4). (D11) CONCOMITANT DEVICE(S): 310-01-50, 1956456 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA). 300-10-45, 2050028 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. 314-02-14, 2055998 - EQUINOXE GLENOID, PEGGED BETA, LARGE. 300-20-02, 2058209 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. (G4) PMA/510(K)NUMBER: K042021. (H4): DEVICE MANUFACTURE DATE: 22-APR-2011 SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D2B) COMMON DEVICE NAME: EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM (D6A) IF IMPLANTED: (B)(6) 2011.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION .

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 10 YEARS POSTOP THIS PATIENT¿S ORIGINAL LEFT TOTAL SHOULDER WAS DONE, HE WAS CONVERTED TO A REVERSE SHOULDER DUE TO A LOOSE HUMERAL STEM. THE STEM WAS EASILY REMOVED AND A LONGER CEMENTED STEM WAS IMPLANTED. CEMENTED GLENOID WAS ALSO EASILY REMOVED AND CONVERTED TO A REVERSE. IT WAS NOTED THAT THERE WAS NOT SIGNIFICANT WEAR ON THE GLENOID BUT POPPED OFF WITHOUT MUCH PRESSURE. NO INFECTION WAS FOUND. PATIENT LEFT IN STABLE CONDITION. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1458612 EQUINOXE EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Hospitalization| R SEE H10