BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 10787983 · Received November 4, 2020

    Report

    Report Number
    1038671-2020-00606
    Event Type
    Injury
    Date Received
    November 4, 2020
    Date of Event
    October 20, 2020
    Report Date
    November 4, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862086655
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE DISLOCATION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND THE RESULT OF LOOSENED SUPPORTING LIGAMENTS AND MUSCLES, WHICH ALLOWED FOR DISLOCATION OCCURRING DUE TO THE SIGNIFICANT LIGAMENT RECONSTRUCTION. (CONCOMITANT MEDICAL PRODUCTS) CONCOMITANT DEVICE(S): 308-08-00, (B)(4) - XS PROX BODY +0. 320-10-00, (B)(4) - EQUINOXE REVERSE TRAY ADAPTER PLATE TRAY +0.

    Description of Event or Problem · 1

    AFTER A PREVIOUSLY REPORTED REVISION OF THE RIGHT SHOULDER, DONE DUE TO THE PATIENT HAVING A HISTORY OF MULTIPLE SHOULDER SURGERIES WITH INFECTION AND BONE LOSS. THE PATIENT WAS SENT TO THE WARD POSTOPERATIVELY. AN RIGHT SHOULDER X-RAY DONE THE FOLLOWING MORNING INDICATED THE PATIENT¿S SHOULDER HAD DISLOCATED OVERNIGHT. THE PATIENT WAS THEN TAKEN BACK TO SURGICAL THEATRE TO INCREASE THE RIGHT SHOULDER TENSION AND STABILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1248233 EQUINOXE REVERSE 38MM HUMERAL LINER +0 KWT EXACTECH, INC. 320-38-00 UNK 10885862086655

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R