BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12405960 · Received September 1, 2021

    Report

    Report Number
    1038671-2021-00458
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 9, 2021
    Report Date
    January 4, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862172716
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF FAILURE OF THE CAGE GLENOID COMPONENT. POSSIBLE CONTRIBUTING FACTORS INCLUDE BUT ARE NOT LIMITED TO INCOMPLETE OR OFF-AXIS SEATING OF THE GLENOID COMPONENT AT THE TIME OF IMPLANTATION, PATIENT CONDITIONS (I.E. POOR BONE QUALITY), AND/OR A POST TRAUMATIC EVENT. THE ROOT CAUSE OF THE FAILURE CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED BECAUSE THE CAGE GLENOID WAS NOT PROVIDED FOR EVALUATION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) DESCRIBE EVENT OR PROBLEM: AS REPORTED, APPROXIMATELY 4 YRS POSTOP THE INITIAL RIGHT TSA, THIS 63 Y/O MALE PATIENT¿S SHOULDER WAS REVISED. THE CAGE HAD SEPARATED FROM THE POLY. HE REMOVED THE HEAD, REPLICATOR PLATE, SCREW, AND THE GLENOID. STEM STAYED. HE GRAFTED THE GLENOID AND LEFT IT. HE THEN REPLACED THE PLATE AND HEAD, LEAVING IT A HEMI. NO BROKEN PARTS WERE LEFT BEHIND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNING, REP WAS NOT ABLE TO RETRIEVE THEM. (H6) COMPONENT CODE: 4720, ANCHOR.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 4 YRS POSTOP THE INITIAL RIGHT TSA, THIS 63 Y/O MALE PATIENT¿S SHOULDER WAS REVISED. THE CAGE HAD SEPARATED FROM THE POLY. HE REMOVED THE HEAD, REPLICATOR PLATE, SCREW, AND THE GLENOID. STEM STAYED. HE GRAFTED THE GLENOID AND LEFT IT. HE THEN REPLACED THE PLATE AND HEAD, LEAVING IT A HEMI. NO BROKEN PARTS WERE LEFT BEHIND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES WILL NOT BE RETURNING, REP WAS NOT ABLE TO RETRIEVE THEM.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-10-15, 4895031 - EQUINOXE REPLICATOR PLATE 1.5MM O/S. 300-20-02, 4424373 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT. 310-02-47, 4070895 - EQUINOXE, HUMERAL HEAD TALL, 47MM (BETA).

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 4 YRS POSTOP THE INITIAL RIGHT TSA, THIS (B)(6) Y/O MALE PATIENT¿S SHOULDER WAS REVISED. THE CAGE HAD SEPARATED FROM THE POLY. HE REMOVED THE HEAD, REPLICATOR PLATE, SCREW, AND THE GLENOID. STEM STAYED. HE GRAFTED THE GLENOID AND LEFT IT. HE THEN REPLACED THE PLATE AND HEAD, LEAVING IT A HEMI. NO BROKEN PARTS WERE LEFT BEHIND. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. DEVICES TO BE RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1306418 EQUINOXE CAGE GLENOID LARGE, BETA KWT EXACTECH, INC. 314-13-14 UNK 10885862172716

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Male Hospitalization| R SEE H10