BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 11985012 · Received June 11, 2021

    Report

    Report Number
    1038671-2021-00293
    Event Type
    Injury
    Date Received
    June 11, 2021
    Date of Event
    May 31, 2021
    Report Date
    April 19, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086662
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF THE POSITIONING OF THE SHOULDER COMPONENTS, SCAPULAR NOTCHING/IMPINGEMENT, AND/OR PATIENT RELATED FACTORS WHICH MAY HAVE LED TO WEAR AND OSTEOLYSIS. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION AND X-RAYS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION: CONCOMITANT DEVICE(S): 320-15-05, 6053517 - EQ REV LOCKING SCREW, 320-20-30, 5943591 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 300-01-15, 5854995 - EQUINOXE, HUMERAL STEM PRIMARY, PRESS FIT 15MM, 320-15-01, 6043945 - EQ REV GLENOID PLATE, 320-20-30, 6082945 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 320-20-30, 6082916 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM, 320-01-38, 6037051 - EQUINOXE REVERSE 38MM GLENOSPHERE, 320-20-26, 6030646 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM, 320-20-00, 6067506 - EQ REVERSE TORQUE DEFINING SCREW KIT. 320-10-00, 6045657 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 22 MONTHS POST-OP THE RTSA, THIS (B)(6) PATIENT WAS REVISED DUE TO POLY WEAR LYSIS. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT RETURN, DISPOSED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    883012 EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 KWT EXACTECH, INC. 320-38-03 UNK 10885862086662

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Hospitalization| R SEE H10