BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8658819 · Received May 31, 2019

    Report

    Report Number
    1038671-2019-00309
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    May 8, 2019
    Report Date
    September 24, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086419
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) EXPIRATION DATE: 24-FEB-2029. (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K063569. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF A DISLOCATION. A REVIEW OF THE DHR AND/OR THE STERILIZATION RECORDS WAS NOT CONDUCTED BECAUSE THE EVENT AS DESCRIBED DOES NOT APPEAR TO BE RELATED TO THE DESIGN, MANUFACTURING, OR REASONABLY FORESEEABLE MISUSE OF THE DEVICE. THE IFU FOR EQUINOXE (700-096-060 REV M) WAS REVIEWED. DEVICE SPECIFIC RISKS INCLUDE, BUT ARE NOT LIMITED TO FRACTURE, MIGRATION, LOOSENING, SUBLUXATION, OR DISLOCATION OF THE PROSTHESIS OR ANY OF ITS COMPONENTS, ANY OF WHICH MAY REQUIRE A SECOND SURGICAL INTERVENTION OR REVISION. NO INFORMATION PROVIDED IN THE FOLLOWING SECTION(S): A4, A5, B6, B7, D6, G8. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (SECTION F) PLEASE DISREGARD F6 AND F8. THESE WERE ENTERED IN ERROR. (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN (B)(6)2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICES: LINER, 42MM, +2.5MM (CN: 320-42-03; SN: (B)(4)); TORQUE DEFINING SCREW (CN: 320-20-00; SN: (B)(4)); GLENOSPHERE LOCKING SCREW (CN: 320-15-05; SN: (B)(4)); GLENOSPHERE, 42MM (CN: 320-01-42; SN: (B)(4)).

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO DISLOCATING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452528 EQUINOXE EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0 KWT EXACTECH, INC. 10885862086419

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention SEE H10.