BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 11627516 · Received April 7, 2021

    Report

    Report Number
    1038671-2021-00157
    Event Type
    Injury
    Date Received
    April 7, 2021
    Date of Event
    January 27, 2021
    Report Date
    September 16, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) CATALOG NUMBER: 314-13-14, SERIAL NUMBER: (B)(6), EXPIRATION DATE: 05-JUL-2020, UNIQUE IDENTIFIER (UDI) #: (B)(4); (D6A) IF IMPLANTED, GIVE DATE: (B)(6) 2016. (D10) CONCOMITANT DEVICES: 300-10-15,4161260 - EQUINOXE REPLICATOR PLATE 1.5MM O/S; 300-20-02, 4021777 - EQUINOX SQUARE TORQUE DEFINE SCREW DRIVE KIT; 310-01-50, 4165427 - EQUINOXE, HUMERAL HEAD SHORT, 50MM (BETA); 320-06-38, 6613207 - GLENOSPHERE 38MM; G4: PMA/510(K)NUMBER: K113309. H3: THE PAIN AND GLENOID LOOSENING REPORTED WAS LIKELY THE RESULT OF INCOMPLETE SEATING OF THE GLENOID COMPONENT DURING IMPLANTATION DUE TO EITHER OFF-AXIS DRILLING OF THE PERIPHERAL HOLES RELATIVE TO THE CENTER CAGE HOLE OR INADEQUATE DRILLING OF THE CENTER CAGE HOLE DURING GLENOID BONE PREPARATION, WHICH ALLOWED FOR THE CENTER CAGE TO EVENTUALLY WEAR THROUGH THE POLYETHYLENE BODY LEADING TO METAL-ON-METAL CONTACT BETWEEN THE CENTER CAGE AND THE HUMERAL HEAD. H4: DEVICE MANUFACTURE DATE: 07-JUL-2015.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 4 YEARS POSTOP THE INITIAL TSA, AN OLDER MALE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS OF PAIN AND LOOSENING IN GLENOID. THE SURGEON PERFORMED A REVISION AND FOUND THE POLY HAD WEAR AND ¿A HOLE IN THE MIDDLE¿ THAT WAS IN LINE TO WHERE THE CENTER CAGE WAS. THE CAGE WAS WELL FIXED TO THE BONE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE SURGEON REQUESTED THE DEVICES WITH INTENTION OF SENDING THEM TO THE MANUFACTURER. DEVICES HAVE NOT BEEN RECEIVED AT THIS TIME. AS REPORTED, APPROXIMATELY 4 YEARS POSTOP THE INITIAL TSA, AN OLDER MALE PATIENT PRESENTED TO THE SURGEON WITH COMPLAINTS OF PAIN AND LOOSENING IN GLENOID. THE SURGEON PERFORMED A REVISION AND FOUND THE POLY HAD WEAR AND ¿A HOLE IN THE MIDDLE¿ THAT WAS IN LINE TO WHERE THE CENTER CAGE WAS. THE CAGE WAS WELL FIXED TO THE BONE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE SURGEON REQUESTED THE DEVICES WITH INTENTION OF SENDING THEM TO THE MANUFACTURER. DEVICES HAVE NOT BEEN RECEIVED AT THIS TIME. PHOTOS WERE RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    523912 EQUINOXE CAGE GLENOID LARGE, BETA KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R SEE H10