BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 10162574 · Received June 17, 2020

    Report

    Report Number
    1038671-2020-00311
    Event Type
    Injury
    Date Received
    June 17, 2020
    Date of Event
    October 11, 2018
    Report Date
    November 3, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086402
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE DISLOCATION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND THE RESULT OF LOOSENED SUPPORTING LIGAMENTS AND MUSCLES, WHICH ALLOWED FOR DISLOCATION OCCURRING DUE TO THE SIGNIFICANT LIGAMENT RECONSTRUCTION. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D4) CATALOG NUMBER: 320-46-13, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 01-NOV-2017, UNIQUE IDENTIFIER (UDI) #: (B)(4).

    Additional Manufacturer Narrative · 1

    (DEVICE EVALUATED BY MFR): PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 320-15-05, 3726546 - EQ REV LOCKING SCREW, 320-20-00, 5250099 - EQ REVERSE TORQUE DEFINING SCREW KIT , 320-46-13, 4509292 - EQUINOXE REVERSE 46MM HUMERAL CONST LINER +2.5, 320-10-15, 2826236 - HUMERAL TRAY +15MM.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 2.5 YRS. POSTOP, A (B)(6) Y/O MALE WITH A ¿LARGER FRAME¿ CAME TO THE OR WITH HIS RIGHT SHOULDER DISLOCATED. AFTER TRAILING, THE SURGEON CHOSE TO IMPLANT THE SAME SIZED COMPONENTS THAT WERE REMOVED. DEVICES WILL NOT BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    627690 EQUINOXE REVERSE 46MM GLENOSPHERE KWT EXACTECH, INC. EQUINOXE REVERSE 46MM GLENOSPHERE UNK 10885862086402

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10