BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9521279 · Received December 26, 2019

    Report

    Report Number
    1038671-2019-00635
    Event Type
    Injury
    Date Received
    December 26, 2019
    Date of Event
    November 6, 2019
    Report Date
    April 7, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) CATALOG NUMBER: 314-13-14, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 21-OCT-2017, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G5) PMA/510(K) NUMBER: K113309, (H4) DEVICE MANUFACTURE DATE: 24-OCT-2012. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D2) CAGE GLENOID LARGE, BETA (D11) CONCOMITANT DEVICE(S): 300-01-13, 2455686 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM; 300-20-02, 2504677 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT; 300-10-45, 2502584 - EQUINOXE REPLICATOR PLATE 4.5MM O/S; 310-01-50, 2358969 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA). *NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): B6, G8, H7, H9.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE WHICH LED TO ASEPTIC (NON-INFECTED) LOOSENING OF THE GLENOID COMPONENT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE EXPLANTED DEVICES WERE NOT AVAILABLE FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION . CONCOMITANT DEVICE(S): HUMERAL STEM, REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD.

    Description of Event or Problem · 1

    AS REPORTED BY THE EQUINOXE SHOULDER STUDY, THIS (B)(6) MALE 5¿8¿, WT. (B)(6) PATIENT HAD AN INITIAL RIGHT TSA ON (B)(6) 2012. THE PATIENT WAS REVISED ON (B)(6) 2019 FOR ASEPTIC GLENOID LOOSENING OF RIGHT SHOULDER TSA. ACCORDING TO THE REPORT, THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1315639 EQUINOXE CAGE GLENOID LARGE, BETA KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Hospitalization| R