BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE TRUNION,41 MM TPS CTD

    MDR report key: 11642947 · Received April 9, 2021

    Report

    Report Number
    1220246-2021-02872
    Event Type
    Injury
    Date Received
    April 9, 2021
    Date of Event
    March 10, 2021
    Report Date
    October 25, 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

    ADDITIONAL INFORMATION: D6A, D6B, G3, H3, H6. 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 OR A TISSUE REACTION TO 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A GLENOID COMPONENT REMOVAL HAD TO BE PERFORMED AS A REVISION SURGERY DUE TO AN ASEPTIC LOOSENING OF THE DEVICE. NO FURTHER INFORMATION RECEIVED. UPDATE 31-MAR-2021: FURTHER INFORMATION WAS RECEIVED. X-RAYS AND PICTURES WERE PROVIDED CONTAINING THE PART- AND LOT-NO. OF ALL INVOLVED DEVICES (AR-9105-01/LOT 1246018, AR-9301-02/LOT 2501252307, AR-9300-41CPC/LOT 2501241206, CD-9341-16/1242003), WHICH WERE PRIMARY IMPLANTED ON THE (B)(6) 2013. THE DATE OF INCIDENT WAS CONFIRMED TO BE THE (B)(6) 2021 ALTHOUGH THE PATIENT HAS EXPERIENCED THE CORRESPONDINGLY LARGE BURDEN ON HER SHOULDERS ALREADY FOR MANY YEARS, BUT HAD TO CARE FOR HER SEVERELY DISABLED HUSBAND. AFTER THE HUSBAND PASSED AWAY, THE PATIENT DECIDED TO HAVE THE OPERATION. DURING THE REVISION A FILLING WITH BONE SUBSTITUTE CERAMENT (HEMI) WAS PERFORMED TO TREAT THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    537954 ECLIPSE TRUNION,41 MM TPS CTD TOTAL SHOULDER ARTHROPLASTY SYSTEM QHQ ARTHREX, INC. ECLIPSE TRUNION,41 MM TPS CTD 2501241206

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Unknown Other