BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8756365 · Received July 2, 2019

    Report

    Report Number
    1038671-2019-00354
    Event Type
    Injury
    Date Received
    July 2, 2019
    Date of Event
    May 30, 2019
    Report Date
    March 27, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862515780
    PMA / PMN Number
    K162726
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (A2) AGE AT THE TIME OF EVEN: 60 YEARS. (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT: ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. (B7) OTHER RELEVANT HISTORY, INCLUDING PREEXISTING MEDICAL CONDITIONS: PATIENT HAS OSTEOARTHRITIS. (D4) EXPIRATION DATE: 09-SEP-2028, SERIAL NUMBER: (B)(6). (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K162726. (H3) THE SUBSIDENCE REPORTED WAS LIKELY THE RESULT OF EITHER UNDER SIZING THE HUMERAL STEM OR INSUFFICIENT BONY SUPPORT FOR THE IMPLANT. HOWEVER, THIS CANNOT BE CONFIRMED BECAUSE THE COMPONENT WAS NOT RETURNED FOR EVALUATION. (H4) DEVICE MANUFACTURE DATE: 11-SEP-2018. THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D11) CONCOMITANT DEVICE(S): EQUINOXE REVERSE 38MM HUMERAL LINER +0 (CN: (B)(4), SN: (B)(6). EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +5 (CN: (B)(4), SN: (B)(6). EQUINOXE REVERSE 38MM GLENOSPHERE (CN: (B)(4), SN: (B)(6). RS GLENOID PLATE R POST AUG, 8 DEG, RIGHT (CN: (B)(4), SN: (B)(6). EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 38MM (CN: (B)(4), SN: (B)(6). EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 42MM (CN: (B)(4), SN: (B)(6). EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM (CN: (B)(4), SN: (B)(6). EQ REV COMPRESS SCREW LCK CAP KIT, 4.5 X 34MM (CN: (B)(4), SN: (B)(6). (SECTION F) PLEASE DISREGARD F6 AND F8. THESE WERE ENTERED IN ERROR. (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN 09-JUN-2019. (H1) TYPE OF REPORTABLE EVENT: SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. PENDING EVALUATION. CONCOMITANT DEVICES: REVERSE HUMERAL LINER (CN: 320-38-00). REVERSE HUMERAL TRAY (CN: 320-10-05). REVERSE GLENOSPHERE (CN: 320-01-38). REVERSE GLENOSPHERE BASEPLATE (CN: 320-15-04). SCREWS X4 (CN: NOT REPORTED).

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2019. X-RAYS SHOW STEM SUBSIDENCE. NO ACTION WAS TAKEN. THE CASE REPORT FORM INDICATES THE EVENT IS POSSIBLY RELATED TO DEVICES AND POSSIBLY RELATED TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    547063 EQUINOXE EQUINOXE PRESERVE STEM 10MM KWT EXACTECH, INC. 300-30-10 10885862515780

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R SEE. H10.