BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 10679115 · Received October 14, 2020

    Report

    Report Number
    1038671-2020-00578
    Event Type
    Injury
    Date Received
    October 14, 2020
    Date of Event
    March 11, 2020
    Report Date
    October 27, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862084538
    PMA / PMN Number
    K093430
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF A ROTATOR CUFF TEAR AND AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) ANATOMIC GLENOID LOOSENING. THIS GLENOID COMPONENT WAS IMPLANTED FOR OVER 8 YEARS PRIOR TO THE REPORTED GLENOID LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS DEVICE(S): 300-01-11, 2233072 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 11MM. 310-01-44, 2012586 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA). 300-10-45, 2234099 - EQUINOXE REPLICATOR PLATE 4.5MM O/S. 300-20-02, 2239296 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT.

    Description of Event or Problem · 1

    AS REPORTED, THIS (B)(6) MALE PATIENT WAS RAISING AN UMBRELLA PAIN STARTED IN HIS LEFT SHOULDER. PATIENT HAS A HISTORY OF OSTEOARTHRITIS AND HYPERTENSION. A REVISION WAS SCHEDULED FOR ASEPTIC GLENOID LOOSENING AND POSTEROSUPERIOR TEAR. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICES AND PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. DEVICES WILL NOT RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1145536 EQUINOXE GLENOID, PEGGED BETA. XLARGE KWT EXACTECH, INC. 314-02-15 UNK 10885862084538

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R