BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9681199 · Received February 7, 2020

    Report

    Report Number
    1038671-2020-00035
    Event Type
    Injury
    Date Received
    February 7, 2020
    Date of Event
    January 31, 2020
    Report Date
    December 18, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086723
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) SERIAL NUMBER: (B)(6), EXPIRATION DATE: 10-MAR-2024. (H3) THE REVISION REPORTED IN CASE: (B)(4) WAS LIKELY THE RESULT OF EITHER INCOMPLETE SEATING OF THE HUMERAL LINER DURING IMPLANTATION, FORCEFUL CONTACT BETWEEN THE LINER AND GLENOID BONE (SCAPULAR NOTCHING), COMPLETE WEAR OF THE LINER, PATIENT CONDITIONS, OR A COMBINATION OF THE FOUR WHICH LED TO THE LINER DISASSOCIATING FROM THE HUMERAL TRAY. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. (H4) DEVICE MANUFACTURE DATE: 12-MAR-2019. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: CONCOMITANT DEVICE: 308-10-00, 5367407 - MED PROX BODY +0, 308-15-01, 5535811 - TAPER LOCKING SCREW 0, 320-02-42, 5610472 - RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET, 320-10-10, 5808447 - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10, 320-15-05, 6216603 - EQ REV LOCKING SCREW, 320-20-00, 6240625 - EQ REVERSE TORQUE DEFINING SCREW KIT.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +10 (CN: 320-10-10; SN: NOT REPORTED).

    Description of Event or Problem · 1

    AS REPORTED, THIS (B)(6) Y/O MALE PATIENT, WEIGHT (B)(6) LBS WAS INITIALLY IMPLANTED WITH A RIGHT TSA ON (B)(6) 2019. A REVISION WAS COMPLETED DUE TO A 42MM +2.5 CONSTRAINED HUMERAL LINER DISASSOCIATING FROM A +10MM HUMERAL ADAPTOR TRAY. IMPLANTS GO TO PATHOLOGY AFTER CASE, WORKING TO RETRIEVE THEM. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    143679 EQUINOXE REVERSE 42MM HUMERAL CONST LINER +2.5 KWT EXACTECH, INC. UNK UNK 10885862086723

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| R SEE H10.