BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 12244783 · Received July 29, 2021

    Report

    Report Number
    1038671-2021-00359
    Event Type
    Injury
    Date Received
    July 29, 2021
    Date of Event
    June 30, 2021
    Report Date
    October 26, 2021
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086709
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF A COMBINATION OF DISLOCATION AND HUMERAL LINER DISASSOCIATION. IT IS UNCLEAR IF THE DISLOCATION ALLOWED FOR THE HUMERAL LINER TO DISASSOCIATE OR IF THE HUMERAL LINER DISASSOCIATION-WHICH MAY HAVE BEEN THE RESULT OF EITHER INCOMPLETE SEATING OF THE LINER DURING IMPLANTATION, BONE IMPINGEMENT, PATIENT CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES-LED TO THE DISLOCATION. HOWEVER, THIS CANNOT BE CONFIRMED AS THE EXPLANTED DEVICES WERE NOT RETURNED FOR EVALUATION. SECTION H11: *THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: (F10) PLEASE DISREGARD HEALTH EFFECT - IMPACT CODE. THESE WERE ENTERED IN ERROR.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION CONCOMITANT DEVICE(S): 300-30-10, 5192593: EQUINOXE PRESERVE STEM 10MM. 320-10-00, 5306458: EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0. 320-01-42, 5299790: EQUINOXE REVERSE 42MM GLENOSPHERE. 320-15-01, 5304655: EQ REV GLENOID PLATE.

    Description of Event or Problem · 1

    AS REPORTED, APPROXIMATELY 3 Y/O POSTOP THE INITIAL RTSA, THE (B)(6) Y/O FEMALE PATIENT EXPERIENCED A MUSCLE SPASM AND DISLOCATED RIGHT SHOULDER. A DISASSOCIATION OF POLYETHYLENE WAS REPORTED. PATENT OUTCOME WAS REPORTED AS ¿CONTINUING¿. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND DEFINITELY NOT RELATED TO PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1141347 EQUINOXE REVERSE 42MM HUMERAL LINER +2.5 KWT EXACTECH, INC. 320-42-03 UNK 10885862086709

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R SEE H10