BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 10060718 · Received May 15, 2020

    Report

    Report Number
    1038671-2020-00293
    Event Type
    Injury
    Date Received
    May 15, 2020
    Date of Event
    May 9, 2020
    Report Date
    June 4, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086693
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF NOT PROPERLY ALIGNING THE GLENOSPHERE RELATIVE TO THE GLENOID BASEPLATE DURING THE INITIAL SURGERY. THIS MISALIGNMENT LIKELY PROHIBITED THE GLENOSPHERE FROM FULLY SEATING AND THE GLENOSPHERE LOCKING SCREW FROM FULLY ENGAGING THE GLENOID BASEPLATE, RESULTING IN DISASSEMBLY OF THE GLENOSPHERE LOCKING SCREW. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTS WERE NOT AVAILABLE FOR EVALUATION. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D4) CATALOG NUMBER: 320-15-05, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 07-JUL-2024, UNIQUE IDENTIFIER (UDI) #:(B)(4). (D11) CONCOMITANT DEVICE(S): 320-42-00, 6090294 - EQUINOXE REVERSE 42MM HUMERAL LINER +0. (H4) DEVICE MANUFACTURE DATE: 10-JUL-2019 (H6) EVALUATION CODE: 3165, 2907.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT MEDICAL DEVICE(S): 320-15-05, (B)(4), EQ REV LOCKING SCREW.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 9 MONTHS POSTOP THE INITIAL IMPLANT, THE (B)(6) Y/O PATIENT PRESENTED FOR THE POSTOPERATIVE CHECK OF THE LEFT SHOULDER. UPON EXAM, IT WAS NOTED THAT THE LOCKING SCREW HAD BACKED OUT SOMEHOW. A REVISION WAS SCHEDULED AND COMPLETED. THE LOCKING SCREW AND HUMERAL LINER WERE REPLACED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES DISPOSED OF BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    527437 EQUINOXE REVERSE 42MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-42-00 UNK 10885862086693

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R