BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE TRUNION,47 MM TPS CTD

    MDR report key: 12576397 · Received October 5, 2021

    Report

    Report Number
    1220246-2021-03739
    Event Type
    Injury
    Date Received
    October 5, 2021
    Date of Event
    August 3, 2021
    Report Date
    September 9, 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

    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. PER DFU-0181-4 REV 0 - E WARNINGS 3. POSTOPERATIVELY AND UNTIL HEALING IS COMPLETE, FIXATION PROVIDED BY THIS DEVICE SHOULD BE CONSIDERED AS TEMPORARY AND MAY NOT WITHSTAND WEIGHT BEARING OR OTHER UNSUPPORTED STRESS. THE FIXATION PROVIDED BY THIS DEVICE SHOULD BE PROTECTED. THE POSTOPERATIVE REGIMEN PRESCRIBED BY THE PHYSICIAN SHOULD BE STRICTLY FOLLOWED TO AVOID ADVERSE STRESSES APPLIED TO THE DEVICE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    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 HAD TO BE PERFORMED DUE TO AN ASEPTIC LOOSENING OF THE DEVICE. THE PATIENT WAS TREATED WITH A SHOULDER PROSTHESIS CHANGE TO AN INVERSE SHOULDER PROSTHESIS. THE CURRENTLY REPORTED DEVICE IS PROBABLY NOT CORRECT AND CURRENTLY THE ACTUALLY AFFECTED DEVICE IS STILL IN CLARIFICATION WITH THE CUSTOMER. NO FURTHER INFORMATION RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1471618 ECLIPSE TRUNION,47 MM TPS CTD TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ECLIPSE TRUNION,47 MM TPS CTD 2501301707

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Other