BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 14207764 · Received April 26, 2022

    Report

    Report Number
    1038671-2022-00462
    Event Type
    Injury
    Date Received
    April 26, 2022
    Date of Event
    April 5, 2022
    Report Date
    August 31, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862534873
    PMA / PMN Number
    K180632
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION: CONCOMITANT DEVICE(S): 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED, 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0, 320-31-36 - GLENOSPHERE, 36MM, 300-30-06 - EQUINOXE PRESERVE STEM 6MM.

    Additional Manufacturer Narrative · 0

    BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SURGICAL EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND THE LOOSENING OF THE CORACOID GPS TRACKER. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D4) CATALOG NUMBER: 320-35-02, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G4) PMA/510(K)NUMBER: K180632. (D10) CONCOMITANT DEVICE(S): 320-36-00 - 36MM HUMERAL LINER +0 UNCONSTRAINED. 320-10-00 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-31-36 - GLENOSPHERE, 36MM. 300-30-06 - EQUINOXE PRESERVE STEM 6MM.

    Description of Event or Problem · 0

    DURING THE INITIAL RIGHT TSA FOR THIS (B)(6) FEMALE PATIENT, THERE WAS A CRACK IN THE CORACOID NOTED DUE TO LOOSENING OF THE CORACOID GPS TRACKER. AT THIS POINT, THE LAST TWO SCREWS WERE PLACED WITHOUT COMPUTER NAVIGATION. THERE WAS NO ACTION TAKEN AND THE OUTCOME IS NOTED AS: CONTINUE TO UPDATE THIS ADVERSE EVENT UNTIL IT HAS BEEN RESOLVED. CURRENTLY, THERE IS NO UPDATED INFORMATION IN THE CLINICAL STUDY DATABASE. THE CASE REPORT FORM INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1590961 EQUINOXE SMALL SUPERIOR AUGMENT GLENOID PLATE KWT EXACTECH, INC. UNK UNK 10885862534873

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| H SEE H10