BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE CAGE SCREW M, 35MM

    MDR report key: 11946730 · Received June 7, 2021

    Report

    Report Number
    1220246-2021-03212
    Event Type
    Injury
    Date Received
    June 7, 2021
    Date of Event
    May 17, 2021
    Report Date
    September 11, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    QHQ
    PMA / PMN Number
    K183194
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED. AN X-RAY WAS PROVIDED, HOWEVER THE X-RAY DID NOT PROVIDE ENOUGH INFORMATION TO CONFIRM OR INVESTIGATE THE COMPLAINT.

    Additional Manufacturer Narrative · 0

    BASED ON THE INFORMATION PROVIDED, WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT THAT MAY OCCUR DUE TO FATIGUE WEAR OF THE IMPLANT.

    Additional Manufacturer Narrative · 1

    THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THE ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED FROM THE INFORMATION AVAILABLE AND WITHOUT DEVICE EVALUATION. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS NECESSARY DUE TO A ASEPTIC LOOSENING OF THE GLENOID. THE SHOULDER PROSTHESIS WAS CHANGED TO AN INVERSE SHOULDER PROSTHESIS. NO FURTHER INFORMATION RECEIVED. 20-MAY-2021 UPDATE: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL IMPLANTATION WAS PERFORMED ON (B)(6) 2016. DURING THE REVISION IT WAS FOUND THAT THE ROTATOR CUFF WAS INTACT AND THAT THERE WAS NO SIGN OF AN INFECTION OR OTHER MORPHOLOGY OF THE BONE. THE PATIENT HAD A STRAIN ACTIVE LIFE STYLE AND WORK. THE PATIENT WAS TREATED WITH A TORNIER AEQUALIS REVERSED II WITH A GLENOID STRUCTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    841559 ECLIPSE CAGE SCREW M, 35MM TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ECLIPSE CAGE SCREW M, 35MM 150045415

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other