BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS REVS TRL GLENOSPHERE 42+2.5 INF

    MDR report key: 19067232 · Received April 8, 2024

    Report

    Report Number
    1220246-2024-01888
    Event Type
    Malfunction
    Date Received
    April 8, 2024
    Date of Event
    March 18, 2024
    Report Date
    August 16, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    LXH
    UDI-DI
    00888867062221
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

    COMPLAINT ALLEGATION IS CONFIRMED. UPON VISUAL INSPECTION, A PIECE OF METAL WAS FOUND INSIDE Ø.1260. ACCORDING TO DRAWING 1002112 REV 0, NO METAL PART IS A COMPONENT OF THE DEVICE. ALSO, IT NOTED THAT THE EDGES AROUND THE ARTHREX® UNIVERS REVERS¿ TRIAL GLENOSPHERE 42 + 2.5 INF HAD BROKEN OFF. -FUNCTIONAL TESTING WAS NOT PERFORMED DUE TO THE DAMAGE TO THE DEVICE. THE FAILURE IS MOST LIKELY DUE TO WEAR AND TEAR FROM REPEATED USE OF A MATING PART. MANUFACTURING DATE 2012.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A UNIVERS REVERSE SURGERY A METAL PIECE OF THE TRIAL IMPLANT BROKE OFF. THERE WAS NO HARM FOR PATIENT, OPERATOR OR THIRD PARTY. THE SURGERY WAS FINISHED SUCCESSFULLY WITH A NEW DEVICE WITH THE SAME PART NUMBER. IT WAS NOT NECESSARY TO SWITCH THE SURGICAL TECHNIQUE OR DO A SECOND SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    109401 UNIVERS REVS TRL GLENOSPHERE 42+2.5 INF ORTHOPEDIC MANUAL SURG INSTR LXH ARTHREX, INC. UNIVERS REVS TRL GLENOSPHERE 42+2.5 INF 250120600 00888867062221

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown