BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8739206 · Received June 27, 2019

    Report

    Report Number
    1038671-2019-00335
    Event Type
    Injury
    Date Received
    June 27, 2019
    Date of Event
    May 29, 2019
    Report Date
    October 22, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079299
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K042021. (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. (H4) DEVICE MANUFACTURE DATE: 04-JAN-2006. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (G4) INITIAL AWARENESS DATE IN INITIAL SUBMISSION SHOULD HAVE BEEN 29-MAY-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    PRIMARY SURGERY: (B)(6) 2007. THE PATIENTS CUFF TORE AND NEEDED TO BE CONVERTED TO A REVERSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534713 EQUINOXE HUMERAL STEM PRIMARY, PRESS FIT 7MM KWT EXACTECH, INC. 10885862079299

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Required Intervention