BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8837795 · Received July 29, 2019

    Report

    Report Number
    1038671-2019-00378
    Event Type
    Injury
    Date Received
    July 29, 2019
    Date of Event
    June 7, 2019
    Report Date
    April 2, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862196170
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) SERIAL NUMBER: (B)(6), EXPIRATION DATE: 18-MAR-2020. (D8) IS THIS A SINGLE-USE DEVICE THAT WAS REPROCESSED AND REUSED ON A PATIENT?: NO. (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K113309. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT NONUNION. THE REPORTED LOOSENING MAY HAVE EITHER BEEN THE RESULT OF DRILLING THE PERIPHERAL PEG HOLES AT AN ANGLE OR NOT FULLY SEATING THE CAGE GLENOID COMPONENT AT THE TIME OF IMPLANTATION, WHICH LED TO THE DISASSOCIATION OF THE METAL PEGS FROM THE POLYETHYLENE BODY OF THE GLENOID COMPONENT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION AND X-RAYS WERE NOT PROVIDED. (H4) DEVICE MANUFACTURE DATE: 25-MAR-2015. (H6) EVALUATION CODES: 1924, 4002 SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (H5) LABELED FOR SINGLE USE?: YES.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    PRIMARY SURGERY: (B)(6) 2019. SURGEON HAD TO DO SURGERY ON A PATIENT WITH NONUNION OF THE TUB. MINUS ON LEFT SHOULDER. HE TREATED THE NONUNION WITHOUT COMPLICATIONS. WHILE HE WAS DOING SO, HE REALIZED THAT THE POLY OF THE GLENOID WAS LOOSE. THE CAGE AND TWO PEGS WHERE TIGHTLY CONNECTED TO THE BONE; ONE PEG WAS STILL CONNECTED TO THE POLY BUT NOT INTEGRATED IN THE BONE. THE POLY WAS SHEERED OF THE CAGE AND THE TWO INTEGRATED PEGS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    631708 EQUINOXE CAGE GLENOID M, POST AUG, LEFT KWT EXACTECH, INC. 314-13-23 10885862196170

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R