BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EQUINOXE

    MDR report key: 10727708 · Received October 23, 2020

    Report

    Report Number
    1038671-2020-00590
    Event Type
    Injury
    Date Received
    October 23, 2020
    Date of Event
    August 29, 2017
    Report Date
    December 16, 2020
    Manufacturer
    EXACTECH, INC.
    Product Code
    KWT
    UDI-DI
    10885862079329
    PMA / PMN Number
    K042021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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 MOST LIKELY CAUSE OF THE REPORTED EVENT WAS A FRACTURE WHICH WAS LIKELY CAUSED DURING PREPARATION FOR IMPLANTATION OF THE SHOULDER.

    Additional Manufacturer Narrative · 1

    PENDING EVALUATION. CONCOMITANT DEVICE(S): 300-10-15, 4911806 - EQUINOXE REPLICATOR PLATE 1.5MM O/S; 310-01-44, 4835494 - EQUINOXE, HUMERAL HEAD SHORT, 44MM (ALPHA); 314-13-03, 4825303 - EQUINOXE CAGE GLENOID MEDIUM, ALPHA.

    Description of Event or Problem · 1

    AS REPORTED, THIS (B)(6) Y/O MALE EXPERIENCED A CRACK IN CALCAR DURING IMPLANT IMPLEMENTATION, NOTED AS AN INTRA-OP RIGHT HUMERAL FRACTURE. THE PLAN POST-PROCEDURE IS SLOW AND CONTROLLED REHABILITATION. THE PATIENT HAS A HISTORY OF RHEUMATORY ARTHRITIS, HYPERTENSION, CHRONIC RENAL FAILURE AND IS ON DIALYSIS. THE CASE REPORT FORM INDICATES THIS EVENT IS POSSIBLY RELATED TO DEVICES AND DEFINITELY RELATED PROCEDURE. THIS EVENT REPORT WAS RECEIVED THROUGH CLINICAL DATA COLLECTION ACTIVITIES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1194548 EQUINOXE HUMERAL STEM PRIMARY, PRESS FIT 13MM KWT EXACTECH, INC. 300-01-13 UNK 10885862079329

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Hospitalization| R