BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9786231 · Received March 4, 2020

    Report

    Report Number
    1038671-2020-00239
    Event Type
    Injury
    Date Received
    March 4, 2020
    Date of Event
    February 26, 2020
    Report Date
    June 4, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (D4) CATALOG NUMBER: 314-13-23, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 16-FEB-2020, UNIQUE IDENTIFIER (UDI) #:(B)(4). (G5) PMA/510(K)NUMBER: K113309. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF THE POLYETHYLENE BODY OF THE GLENOID COMPONENT BECOMING DISASSOCIATED FROM THE METAL PEGS WHICH MAY HAVE BEEN DUE TO DRILLING THE PERIPHERAL PEG HOLES AT AN ANGLE OR NOT FULLY SEATING THE CAGE GLENOID COMPONENT AT THE TIME OF IMPLANTATION. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION AND X-RAYS WERE NOT PROVIDED. (H4) DEVICE MANUFACTURE DATE: 18-FEB-2015. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D11) CONCOMITANT DEVICE(S): 300-01-13, 4096120 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 13MM. 300-20-02, 4138157 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 300-50-15, 3894539 - 1.5MM SHORT REP PLATE. 310-00-47, 4132697 - XS HUMERAL HEAD, 47MM XS OFFSET HUMERAL HEAD.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AS REPORTED BY THE (B)(6) STUDY, APPROXIMATELY 52 MONTHS POSTOPERATIVE THE INITIAL IMPLANT, THIS (B)(6) Y/O MALE PATIENT, WEIGHT (B)(6) LBS EXPERIENCED A DISASSOCIATION OF POLYETHYLENE OF THE LEFT SHOULDER, SHEAR FAILURE WITHOUT MECHANISMS. THE EVENT IS RELATED TO THE DEVICE AND POSSIBLY RELATED TO THE PROCEDURE. DEVICE WILL NOT BE RETURNED DUE TO THIS IS A STUDY PATIENT. NO OTHER INFORMATION AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248773 EQUINOXE GLENOID KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| R