BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9890532 · Received March 27, 2020

    Report

    Report Number
    1038671-2020-00264
    Event Type
    Injury
    Date Received
    March 27, 2020
    Date of Event
    March 6, 2020
    Report Date
    June 2, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K092900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) CATALOG NUMBER: 304-22-11, SERIAL NUMBER: (B)(4). EXPIRATION DATE: 04-MAY-2026, UNIQUE IDENTIFIER (UDI) #: (B)(4) (G5) PMA/510(K)NUMBER: K092900 (H3) THE REVISION DUE TO HUMERAL LOOSENING REPORTED IS MOST LIKELY A COMBINATION OF ASEPTIC LOOSENING AND PATIENT-RELATED CONDITIONS. (H4) DEVICE MANUFACTURE DATE: 04-MAY-2016 SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D11) CONCOMITANT DEVICE(S): 320-15-05, 4489051 - EQ REV LOCKING SCREW 320-10-00, 4495395 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 320-20-00, 4424563 - EQ REVERSE TORQUE DEFINING SCREW KIT 320-20-30, 4477372 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 320-15-01, 4229052 - EQ REV GLENOID PLATE 320-20-18, 4450159 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 18MM 320-20-26, 4447022 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 26MM 320-02-38, 4406689- RS EXPANDED GLENOSPHERE 38MM, +4MM OFFSET 320-20-30, 4471761 - EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 30MM 320-38-03, 4337865 - EQUINOXE REVERSE 38MM HUMERAL LINER +2.5 *NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): B6, G5, G8, H7, H9

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): HUMERAL TRAY, TORQUE SCREW, HUMERAL LINER, GLENOSPHERE, GLENOSPHERE LOCKING SCREW, COMPRESSION SCREW/LOCKING CAP.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 3.5 YEARS POST IMPLANTATION OF A REVERSE PROSTHESIS, A REVISION WAS COMPLETED ON THIS (B)(6)Y/0 FEMALE DUE TO ASEPTIC GLENOID LOOSENING. GRADUAL LUCENCIES AROUND RIGHT HUMERAL COMPONENT NOTED. THE STUDY INDICATED THE EVENT IS POSSIBLY RELATED TO THE DEVICE AND DEFINITELY RELATED TO THE PROCEDURE. PATIENT WAS REVISED TO REVERSE WITH HUMERAL RECONSTRUCTION STEM. PATIENT WAS AN INPATIENT X 3DAYS. PATIENT HAS HISTORY OF SMOKING AND LIVER DISEASE. NO OTHER INFORMATION IS AVAILABLE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    353334 EQUINOXE FRACTURE HUMERAL STEM KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R