BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8659581 · Received May 31, 2019

    Report

    Report Number
    1038671-2019-00317
    Event Type
    Injury
    Date Received
    May 31, 2019
    Date of Event
    May 17, 2019
    Report Date
    December 3, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862172693
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (B2) ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED (B5) AS REPORTED, A 62 Y/O PATIENT WHO WEIGHED 73LBS, WAS INITIALLY IMPLANTED DURING A TSA (B)(6) 2016. A REVISION WAS COMPLETED ON (B)(6) 2019 DUE TO THE SURGEON BELIEVED THE POLY WAS NEVER FULLY SEATED AND THUS CREATED A ROCKING HORSE EFFECT GENERATING FORCES THAT SNAPPED THE CENTER CAGE. THE PATIENT WAS REVISED TO A REVERSE AND THE PATIENT IS DOING WELL. PATIENT WAS STABLE AS THEY LEFT THE OR. EXPLANTS AND ALL DEBRIS WAS REMOVED FROM THE PATIENT. UPON REVIEW OF ALL AVAILABLE INFORMATION AND EXAMINATION OF THE DEVICES, THE REVISION REPORTED IN (B)(4) WAS LIKELY THE RESULT OF THE CAGED GLENOID NOT BEING FULLY SEATED AT THE TIME OF IMPLANTATION WHICH ¿CREATED A ROCKING HORSE EFFECT GENERATING FORCES THAT SNAPPED THE CENTER CAGE (PEG)¿ AND CAUSE A PROSTHESIS FRACTURE. THE PATIENT WAS REVISED TO A REVERSE SHOULDER. (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K113309. (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF THE CAGED GLENOID NOT BEING FULLY SEATED AT THE TIME OF IMPLANTATION WHICH ¿CREATED A ROCKING HORSE EFFECT GENERATING FORCES THAT SNAPPED THE CENTER CAGE (PEG).¿ THE PATIENT WAS REVISED TO A REVERSE SHOULDER. 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 16-MAY-2019.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    DOCTOR IMPLANTED A CAGE GLENOID WITH A SIMPLICITI STEMLESS NUCLEUS. HE BELIEVES THE POLY WAS NEVER FULLY SEATED AND THUS CREATED A ROCKING HORSE EFFECT GENERATING FORCES THAT SNAPPED THE CENTER CAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    452570 EQUINOXE EQUINOXE CAGE GLENOID MEDIUM, BETA KWT EXACTECH, INC. UNK UNK 10885862172693

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Hospitalization| R