BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8663070 · Received June 3, 2019

    Report

    Report Number
    1038671-2019-00322
    Event Type
    Injury
    Date Received
    June 3, 2019
    Date of Event
    May 22, 2019
    Report Date
    April 7, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086389
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (D6) IF IMPLANTED, GIVE DATE: (B)(6) 2018. (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K063569. (H4) DEVICE MANUFACTURE DATE: 03-OCT-2018. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF NOT PROPERLY ALIGNING THE GLENOSPHERE RELATIVE TO THE GLENOID BASEPLATE DURING THE INITIAL SURGERY. THIS MISALIGNMENT LIKELY PROHIBITED THE GLENOSPHERE FROM FULLY SEATING AND THE GLENOSPHERE LOCKING SCREW FROM FULLY ENGAGING THE GLENOID BASEPLATE, RESULTING IN DISASSOCIATION OF THE GLENOSPHERE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTS WERE NOT AVAILABLE FOR EVALUATION. (H6) EVALUATION CODES: 3165, 2907. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (SECTION F) PLEASE DISREGARD F6 AND F8. THESE WERE ENTERED IN ERROR. (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN 22-MAY-2019 (H5) LABELED FOR SINGLE USE?: YES.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES (2): EQ REV LOCKING SCREW (CN: 320-15-05; SN: (B)(4)). EQUINOXE REVERSE 38MM HUMERAL LINER +0 (CN: 320-38-00; SN: (B)(4)).

    Description of Event or Problem · 1

    PRIMARY SURGERY: (B)(6) 2018. THE GLENOSPHERE WAS FOUND UNCOUPLED ON THE X-RAY AT A 6 MONTH FOLLOW UP WITH THE PATIENT. PATIENT WAS ASYMPTOMATIC, NO PAIN AND WITH FULL FUNCTIONING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456800 EQUINOXE EQUINOXE REVERSE 38MM GLENOSPHERE KWT EXACTECH, INC. 320-01-38 10885862086389

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R