BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9207639 · Received October 18, 2019

    Report

    Report Number
    1038671-2019-00522
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    February 21, 2018
    Report Date
    April 7, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) CATALOG NUMBER: 320-10-00, SERIAL NUMBER: (B)(6) , EXPIRATION DATE: 01-MAY-2027, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G5) PMA/510(K)NUMBER: K063569. (H4) DEVICE MANUFACTURE DATE: 02-MAY-2017. (H6) EVALUATION CODES: 1924, 4002. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (D1) COMMON DEVICE NAME: REVERSE TRAY ADAPTER PLATE TRAY +0 (D11) CONCOMITANT DEVICE(S): EQUINOXE REVERSE 42MM HUMERAL LINER +0 (CN: 320-42-00 / SN: (B)(6)).

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE IMPLANT AND THE BONE AND PATIENT CONDITIONS, WHICH LED TO ASEPTIC (NON-INFECTED) HUMERAL LOOSENING, PAIN, AND NON-UNION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTED DEVICES WERE NOT AVAILABLE FOR EVALUATION. THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (B5) AS REPORTED, APPROXIMATELY 18 MONTHS POSTOP THE INITIAL TSA, THIS 52 Y/O FEMALE COMPLAINED OF EXTREME PAIN IN SHOULDER DUE TO ASEPTIC HUMERAL LOOSENING AND NON-UNION. THE CASE REPORT FORM INDICATES THIS EVENT WAS RESOLVED WITH REVISION SURGERY ON (B)(6) 2018 AND INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES. (D1) COMMON DEVICE NAME: EQUINOXE, HUMERAL LONG STEM 8MM 175MM. (D4) CATALOG NUMBER: 306-01-08, SERIAL NUMBER: (B)(6) , EXPIRATION DATE: 02-APR-2022, UNIQUE IDENTIFIER (UDI) #: (B)(4). (D11) CONCOMITANT DEVICE(S): 320-10-00, 4875737, EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-42-00, 4361319, EQUINOXE REVERSE 42MM HUMERAL LINER +0. 320-20-00, 4852547, EQ REVERSE TORQUE DEFINING SCREW KIT. (G5) PMA/510(K)NUMBER: K042021. (H4) DEVICE MANUFACTURE DATE: 02-APR-2012.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 18 MONTHS POSTOP THE INITIAL TSA, THIS 52 Y/O FEMALE COMPLAINED OF EXTREME PAIN IN SHOULDER DUE TO ASEPTIC HUMERAL LOOSENING AND NON-UNION. THE CASE REPORT FORM INDICATES THIS EVENT WAS RESOLVED WITH REVISION SURGERY ON (B)(6) 2018 AND INDICATES THIS EVENT IS UNLIKELY RELATED TO DEVICES AND DEFINITELY RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. HUMERAL LINER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PRIMARY SURGERY OCCURRED ON (B)(6) 2017. THE PATIENT HAS HAD A REVISION DUE TO ASEPTIC HUMERAL LOOSENING. EXTREME PAIN IN SHOULDER DUE TO HUMERAL LOOSENING AND NON-UNION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1005405 EQUINOXE EQUINOXE, HUMERAL LONG STEM 8MM 175MM KWT EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R