BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12745762 · Received November 3, 2021

    Report

    Report Number
    1038671-2021-00575
    Event Type
    Injury
    Date Received
    November 3, 2021
    Date of Event
    October 14, 2021
    Report Date
    March 1, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) CATALOG NUMBER: 314-13-03, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 11-JUL-2017, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G4) PMA/510(K)NUMBER: K113309. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND AN INSUFFICIENT ROTATOR CUFF. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. ADDITIONAL CONTRIBUTIONS OF IMPLANT ALIGNMENT, GLENOID LOOSENING, AND PATIENT-RELATED CONDITIONS AS WELL AS THE SEQUENCE OF EVENTS LEADING TO THE REVISION CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED. (H4) DEVICE MANUFACTURE DATE: 12-JUL-2012 SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D11) CONCOMITANT DEVICE(S): 300-10-15, 2494735 - EQUINOXE REPLICATOR PLATE 1.5MM O/S, 300-20-02, 2504551 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT, 310-01-44, 2506040 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA).

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION CONCOMITANT DEVICE(S): HUMERAL HEAD.

    Description of Event or Problem · 1

    APPROXIMATELY 9 YRS POSTOP THE INITIAL RTSA, THIS (B)(6) FEMALE PATIENT UNDERWENT A REVISION OF THE ANATOMICAL SHOULDER TO REVERSE SHOULDER WAS COMPLETED, DUE TO GLENOID WEAR AND ROTATOR CUFF INSUFFICIENT. THE CAGE GLENOID AND HUMERAL HEAD. REPLACED WITH A 38 GLENOID STANDARD CAGE. WITH A 2.5 LINER AND ZERO TRAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN DUE TO SURGEON¿S REQUEST.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1647875 EQUINOXE CAGE GLENOID MEDIUM, ALPHA KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Female Hospitalization| R SEE H10