BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8369746 · Received February 26, 2019

    Report

    Report Number
    1038671-2019-00093
    Event Type
    Injury
    Date Received
    February 26, 2019
    Date of Event
    February 6, 2019
    Report Date
    December 6, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K113309
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    ADDED CHECK FOR HOSPITALIZATION - INITIAL OR PROLONGED. RELEVANT TEST/THERAPY DATES: INDEX SURGERY: (B)(6)2018. REVISION DUE TO POSSIBLE INFECTION. THE PATIENT CAME UP FOR A FOLLOW UP AND COMPLAINED OF SHOULDER PAIN. AN X-RAY WAS TAKEN AND FAILURE OF THE GLENOID WAS NOTICED; THE GLENOID CAGE HAD BROKEN OFF THE POLY. IT SHOULD BE NOTED THAT THE PATIENT HAD ANOTHER TSA DONE WITH GPS ON (B)(6) 2018. PRIOR TO COMPLAINING OF SHOULDER PAIN THE PATIENT WAS VERY HAPPY, THUS THE REASON SHE GOT HER OTHER SHOULDER. DURING THE DATE OF THE REVISION CASE THE INITIAL PLAN WAS TO CONVERT TO A REVERSE, HOWEVER THE PATIENT¿S ESR WAS 37 (NORMAL < 30) AND CRP WAS 0.4 (NORMAL < 0.3) SO IT WAS DECIDED TO EXPLANT AND PUT IN A SPACER. ALL ITEMS WERE REMOVED WITHOUT TOO MUCH TROUBLE. GLENOID HAS A BIG CAVITARY DEFECT BUT SHOULD NOT CAUSE ANY PROBLEMS. PATIENT'S HEALTH WAS STABLE LEAVING THE OPERATING ROOM. EXPIRATION DATE: 09-APR-2018, UNIQUE IDENTIFIER (UDI) #: (B)(4). INITIAL REPORTER OCCUPATION: PHYSICIAN. PMA/510(K)NUMBER: K113309. THE REVISION REPORTED WAS LIKELY THE RESULT OF DRILLING THE HOLE FOR THE CAGE GLENOID TO AN INSUFFICIENT DEPTH, WHICH RESULTED IN THE CAGE BOTTOMING OUT ON THE MEDIAL SCAPULAR WALL. THE GLENOID CAVITY DEFECT PRESENT IN THE PATIENT LIKELY CONTRIBUTED TO THE FAILURE OF THE CAGE GLENOID BY PROVIDING INSUFFICIENT SUPPORT TO THE CAGE GLENOID. DEVICE MANUFACTURE DATE: 12-APR-2013. EVALUATION CODES: 1735, 2993. CORRECTIONS MADE IN THE FOLLOWING SECTION(S): INITIAL REPORTER NAME: DR. (B)(6) AT (B)(6) HOSPITAL. HEALTH PROFESSIONAL? YES. MDR REPORTING CONTACT NAME: (B)(6). REPORT SOURCE: HEALTH PROFESSIONAL.

    Description of Event or Problem · 0

    INDEX SURGERY: (B)(6) 2018. REVISION DUE TO POSSIBLE INFECTION. THE PATIENT CAME UP FOR A FOLLOW UP AND COMPLAINED OF SHOULDER PAIN. AN X-RAY WAS TAKEN AND FAILURE OF THE GLENOID WAS NOTICED; THE GLENOID CAGE HAD BROKEN OFF THE POLY. IT SHOULD BE NOTED THAT THE PATIENT HAD ANOTHER TSA DONE WITH GPS ON (B)(6) 2018. PRIOR TO COMPLAINING OF SHOULDER PAIN THE PATIENT WAS VERY HAPPY, THUS THE REASON SHE GOT HER OTHER SHOULDER. DURING THE DATE OF THE REVISION CASE THE INITIAL PLAN WAS TO CONVERT TO A REVERSE, HOWEVER THE PATIENT¿S ESR WAS 37 (NORMAL < 30) AND CRP WAS 0.4 (NORMAL < 0.3) SO IT WAS DECIDED TO EXPLANT AND PUT IN A SPACER. ALL ITEMS WERE REMOVED WITHOUT TOO MUCH TROUBLE. GLENOID HAS A BIG CAVITARY DEFECT BUT SHOULD NOT CAUSE ANY PROBLEMS. PATIENT'S HEALTH WAS STABLE LEAVING THE OPERATING ROOM.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2018. REVISION DUE TO POSSIBLE INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    162996 EQUINOXE EQUINOXE CAGE GLENOID MEDIUM, ALPHA KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Hospitalization| R