BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 9860929 · Received March 20, 2020

    Report

    Report Number
    1038671-2020-00251
    Event Type
    Injury
    Date Received
    March 20, 2020
    Date of Event
    January 1, 2017
    Report Date
    October 2, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    PMA / PMN Number
    K063569
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (D4) CATALOG NUMBER: 320-42-10, UNIQUE IDENTIFIER (UDI) #: (B)(4). (G5) PMA/510(K)NUMBER: K063569. (H3) BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN, MANUFACTURING, OR PATIENT RELATED ISSUES. THE CAUSE OF THE REVISION IS MOST LIKELY IS RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION.

    Description of Event or Problem · 1

    AS REPORTED, THE ELDERLY AND SKINNY MALE PATIENT HAD FAILURE OF A REVERSE TOTAL SHOULDER DUE TO DISLOCATION IN 2017. THE INITIAL IMPLANT DATE IS UNKNOWN. THIS PATIENT HAS A HISTORY OF FALLING AND DISLOCATING HIS SHOULDER. ALL AVAILABLE INFORMATION HAS BEEN PROVIDED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323307 EQUINOXE LINER KWT EXACTECH, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R