BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8969016 · Received September 6, 2019

    Report

    Report Number
    1038671-2019-00446
    Event Type
    Injury
    Date Received
    September 6, 2019
    Date of Event
    August 26, 2019
    Report Date
    February 6, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862242556
    PMA / PMN Number
    K131575
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (E3) OCCUPATION: PHYSICIAN. (G3) REPORT SOURCE: HEALTH PROFESSIONAL. (G5) PMA/510(K)NUMBER: K131575. (H3) THE DISASSEMBLY REPORTED MAY HAVE BEEN THE RESULT OF MISALIGNING THE GLENOSPHERE ON THE GLENOID BASEPLATE DURING THE INITIAL SURGERY, WHICH MAY HAVE PREVENTED THE GLENOSPHERE LOCKING SCREW FROM FULLY SEATING, ALLOWING FOR THE SCREW TO BACKOUT OF THE BASEPLATE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. (H4) DEVICE MANUFACTURE DATE: (B)(6) 2015. (H6) EVALUATION CODES: 3165. 2907. *NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A3, A4, A5, B6, B7, D6, G8, H7, H9.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE: GLENOSPHERE LOCKING SCREW (CAT# 320-15-05 / SN# (B)(4)) ; GLENOSPHERE (CAT# 320-01-38 / SN# (B)(4)).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REVISION WAS DUE TO THE GLENOSPHERE BECOMING DISASSOCIATED FROM THE BASE PLATE TWO MONTHS AFTER THE INITIAL IMPLANT SURGERY. THE SURGEON USED THE SUPERIOR POSTERIOR GLENOID PLATE, A 38 GLENOSPHERE AND THE GLENOSPHERE LOCKING SCREW. HE ENCOUNTERED NO PROBLEM DURING THE FIRST SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    764379 EQUINOXE SUP/POST AUG PLATE, L RS GLENOID BASEPLATE KWT EXACTECH, INC. UNK UNK 10885862242556

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R