BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8770972 · Received July 9, 2019

    Report

    Report Number
    1038671-2019-00364
    Event Type
    Injury
    Date Received
    July 9, 2019
    Date of Event
    June 28, 2017
    Report Date
    December 18, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED HOSPITALIZATION INITIAL OR PROLONGED. CATALOG NUMBER: 314-02-02, SERIAL NUMBER: (B)(4), EXPIRATION DATE: 18-JUL-2010, UNIQUE IDENTIFIER (UDI) #, (B)(4). OCCUPATION: PHYSICIAN. PMA/510(K)NUMBER: K042021. THE REVISION REPORTED WAS LIKELY THE RESULT OF A ROTATOR CUFF TEAR AND/OR AN INSUFFICIENT BOND BETWEEN THE BONE AND THE IMPLANT WHICH LED TO ASEPTIC (NON-INFECTED) GLENOID LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTS WERE NOT AVAILABLE FOR EVALUATION AND NO OTHER INFORMATION WAS PROVIDED. DEVICE MANUFACTURE DATE: 20-JUL-2005. EVALUATION CODES: 1924, 4002. CORRECTIONS MADE IN THE FOLLOWING SECTION(S): CONCOMITANT DEVICE(S): 300-20-02, (B)(4), EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 300-01-09, (B)(4),EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 9MM. 300-10-15, (B)(4), EQUINOXE REPLICATOR PLATE 1.5MM O/S. 310-01-41, (B)(4), EQUINOXE, HUMERAL HEAD SHORT, 41MM (ALPHA).

    Additional Manufacturer Narrative · 1

    THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. PENDING EVALUATION. CONCOMITANT DEVICES: HUMERAL STEM, REPLICATOR PLATE, TORQUE SCREW, HUMERAL HEAD.

    Description of Event or Problem · 1

    PRIMARY SURGERY: (B)(6) 2007. REVISION DUE TO ASEPTIC GLENOID LOOSENING AND POSTERIOR SUP RTC, DEGENERATIVE RCT. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565760 EQUINOXE GLENOID KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Hospitalization| R