BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNIVERS REVERS GLENOID

    MDR report key: 18780304 · Received February 26, 2024

    Report

    Report Number
    1220246-2024-01127
    Event Type
    Injury
    Date Received
    February 26, 2024
    Date of Event
    February 6, 2024
    Report Date
    September 4, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    PMA / PMN Number
    K142863
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED BASED ON THE PHOTOS PROVIDED BY THE CUSTOMER. VISUAL EVALUATION REVEALED AN EXPLANTED PERIPHERAL SCREW (PN UNKNOWN). IN ADDITION, A PHOTO OF THE METALLOSIS WAS ALSO PROVIDED. THE HEAD, TINBN, IS AN INFERIOR BEARING SURFACE THAN THE STANDARD COBALT CHROME. LIKELY DONE DUE TO THE PATIENT HAVING A NICKEL ALLERGY. THIS BEARING SURFACE MAY HAVE CONTRIBUTED TO WEARING THE POLY MORE QUICKLY. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Additional Manufacturer Narrative · 0

    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 · 0

    UPDATE 08-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT THE DEVICES WERE INITIALLY IMPLANTED IN 2016. UPDATE 28-MAR-2024: FURTHER INFORMATION WERE PROVIDED THAT THE INITIAL SURGERY WAS PERFORMED ON (B)(6) 2017.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION OF AN ECLIPSE WITH UNIVERSAL GLENOID WAS NECESSARY DUE TO WEAR OF THE POLYETHYLENE GLENOID OF THE UNIVERSAL GLENOID BASE PLATE. IT WAS FURTHER REPORTED THAT THE ISSUE CAUSE A STRONG METALLOSIS DUE TO THE METAL TO METAL FRICTION. THE FOLLOWING DEVICES WERE EXPLANTED DURING THE REVISION SURGERY: CD-9341-16 ECLIPSE HEAD, SIZE 41/16 TINBN COATED AR-9300-41CPC ECLIPSE TRUNION,41 MM TPS CTD AR-9301-02 ECLIPSE CAGE SCREW M, 35MM AR-9120-01 UNIVERSAL GLENOID - BASEPLATE SMALL AR-9165-20 UNIVERSAL GLENOID - CENTRAL SCREW 20MM 2X UNKNOWN PERIPHERAL SCREWS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2000712 UNIVERS REVERS GLENOID SHOULDR PROSTH, REVERSE CONFIG PHX ARTHREX, INC. UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other