BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ECLIPSE TRUNION 49MM

    MDR report key: 9457381 · Received December 12, 2019

    Report

    Report Number
    1220246-2019-01476
    Event Type
    Injury
    Date Received
    December 12, 2019
    Date of Event
    November 18, 2019
    Report Date
    February 12, 2020
    Manufacturer
    ARTHREX, INC.
    Product Code
    PKC
    PMA / PMN Number
    K183914
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED FOR INFECTION. SOME DAMAGE WAS OBSERVED ON THE AR-9300-49 DEVICE WHICH MOST LIKELY OCCURRED DURING THE REMOVAL OF THE IMPLANT. ADDITIONALLY, THE WEAR OBSERVED ON THE POLY AR-9102-02 AND BASE PLATE AR-9101-02 WAS LIKELY CAUSED BY AN ALIGNMENT ISSUE RESULTING IN THE DESCRIBED METALOSIS. THE ORIGIN OF THE ALIGNMENT ISSUE IS UNKNOWN.

    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 PROSTHESIS WAS REMOVED AFTER SEVERAL YEARS. THE PE GLENOID WAS WORN OUT AND A METALOSIS OCCURRED. IN ADDITION, AN INFECTION MANIFESTED ITSELF BEHIND THE METALBACK OF THE PROSTHESIS. THE SURGEON DID NOT IMPLANT A NEW PROSTHESIS. ACCORDING TO THE SURGEON THE SURGERY WAS NOT COMPLETED SUCCESSFULLY AND AS PLANNED BECAUSE HE NEEDED TO DECIDE ON THE GIRDLESTONE SITUATION. ALSO TWO FURTHER DEVICES WILL BE SENT IN FOR EVALUATION. AR-9101-2 - LOT 06.138. AR-9101-13 - LOT. 06.140.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1255653 ECLIPSE TRUNION 49MM PROSTHESIS, TOTAL ANATOMIC SHOULDER, UNCEMENTED METAPHYSEAL HUMERAL STEM WITH NO PKC ARTHREX, INC. ECLIPSE TRUNION 49MM 06019

    Patients

    Seq Age Sex Outcome Treatment
    1 Other