BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 8394342 · Received March 6, 2019

    Report

    Report Number
    1038671-2019-00121
    Event Type
    Injury
    Date Received
    March 6, 2019
    Date of Event
    February 19, 2019
    Report Date
    December 10, 2019
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K110708
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (A1) PATIENT IDENTIFIER: (B)(6). (B2) OUTCOMES ATTRIBUTED TO ADVERSE EVENT: REQUIRED INTERVENTION TO PREVENT PERMANENT IMPAIRMENT/DAMAGE (DEVICES), HOSPITALIZATION - INITIAL OR PROLONGED. (D1) BRAND NAME: EQUINOXE. (D4) EXPIRATION DATE: 17-JAN-2027. UNIQUE IDENTIFIER (UDI) #: (B)(4). (E3) OCCUPATION: PHYSICIAN. (G5) PMA/510(K)NUMBER: K110708. (H3) IN A REVIEW OF THE LABELING AND IFU 700-096-004 REV. N, THE PATIENT SHOULD BE CAUTIONED TO MONITOR ACTIVITIES AND PROTECT THE REPLACED JOINT FROM UNREASONABLE STRESSES, AND FOLLOW THE WRITTEN INSTRUCTIONS OF THE PHYSICIAN WITH RESPECT TO FOLLOW-UP CARE AND TREATMENT. UPON REVIEW OF THE AVAILABLE INFORMATION, THERE IS NO EVIDENCE THAT THIS IS A DEVICE RELATED PROBLEM AND THERE IS NO ALLEGATION AGAINST THE DEVICE. IMPLANTATION OF A TOTAL JOINT COULD RESULT PAIN, INFECTION, OR LOOSENING OF TOTAL JOINT HARDWARE. THE MOST LIKELY CAUSE OF THE REPORTED EVENT IS AN ADVERSE EVENT WITHOUT IDENTIFIED DEVICE OR USE PROBLEM. (H4) DEVICE MANUFACTURE DATE: 18-JAN-2017. (H6) EVALUATION CODES: 2374, 2993. SECTION H11: CORRECTIONS MADE IN THE FOLLOWING SECTION(S): (B5) AS REPORTED, A PATIENT WHO WAS INITIALLY IMPLANT WITH A REVERSE SHOULDER ON 3/30/201. PATIENT PRESENTED TO SURGEON WITH A REVERSE SHOULDER REPLACEMENT, WHICH WAS NOT FULLY STABLE AND HAD DISLOCATED. THE SURGEON PLANNED TO OPERATE AND INCREASE THE SIZE OF THE GLENOSPHERE AND LINER COMPONENTS. DURING THE REVISION, A CONSTRAINED LINER WAS USED TO BETTER PREVENT ANY INSTABILITY. THE SURGEON EXPECTS THIS TO FIX THIS PATIENTS INSTABILITY AND EXPECTS THE PATIENT TO DO WELL. PATIENT WAS STABLE UPON LEAVING THE OPERATING ROOM (E1) INITIAL REPORTER NAME: DR. (B)(6) HOSPITAL. (E2) YES. (G1) MDR REPORTING CONTACT NAME: (B)(6). (G3) REPORT SOURCE: HEALTH PROFESSIONAL.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PRIMARY SURGERY OCCURRED ON (B)(6) 2017. REVISION DUE TO DISLOCATION. PATIENT PRESENTED TO SURGEON WITH A REVERSE SHOULDER REPLACEMENT, WHICH WAS NOT FULLY STABLE AND HAD DISLOCATED. THE SURGEON CHOSE TO OPERATE AND INCREASE THE SIZE OF THE GLENOSPHERE AND LINER COMPONENTS. THE SURGEON ALSO USED A CONSTRAINED LINER TO BETTER PREVENT ANY INSTABILITY. HE EXPECTS THIS TO WORK TO FIX THIS PATIENTS INSTABILITY AND EXPECTS THE PATIENT TO DO WELL. PATIENT WAS STABLE UPON LEAVING THE OPERATING ROOM. ALL AVAILABLE INFORMATION HAS BEEN RECEIVED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    INDEX SURGERY: (B)(6) 2017. REVISION DUE TO DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190673 EQUINOXE RS EXPANDED GLENOSPHERE 42MM, +4MM OFFSET KWT EXACTECH, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Hospitalization| R