BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERS VAULTLOCK GLENOID, SMALL

    MDR report key: 18439579 · Received January 3, 2024

    Report

    Report Number
    1220246-2024-00067
    Event Type
    Malfunction
    Date Received
    January 3, 2024
    Date of Event
    June 4, 2020
    Report Date
    January 3, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    UDI-DI
    00888867239319
    PMA / PMN Number
    K161108
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED. THE DEVICE WAS NOT RETURNED FOR EVALUATION; NO PICTURES WERE PROVIDED. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT.

    Description of Event or Problem · 0

    ON JULY 11, 2022, A NOTIFICATION WAS RECEIVED INDICATING THAT A PATIENT, LISTED ON THE SHOULDER ARTHROPLASTY REGISTRY, IS EXPERIENCING WORSENING PAIN. AN X-RAY SHOWS A DISLODGED GLENOID COMPONENT. SURGEON HAS SCHEDULED THE PATIENT FOR A REVISION SURGERY TO AN RSA ON (B)(6) 2022. ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2020. ADDITIONAL INFORMATION RECEIVED ON 7/12/2022: DURING SURGERY ON (B)(6) 2020, A TOTAL OF (B)(4) ARTHREX DEVICES WERE IMPLANTED. AN AR-9301-03 ECLIPSE CAGE SCREW LARGE, LOT NUMBER 19.00501, AN AR-9301-43CPC ECLIPSE TRUNION, LOT NUMBER 18-01245, AN AR-9343-16 ECLIPSE HUMERAL HEAD, LOT NUMBER 1917001, AND AN AR-9106-01 UNIVERS VAULTLOCK GLENOID. AS OF NOW, NOTHING HAS SHOWN TO BE BROKEN INSIDE THE PATIENT BUT THERE'S AS DISLODGMENT OF GLENOID PROSTHESIS. ADDITIONAL INFORMATION RECEIVED ON 7/25/2022: ACCORDING TO FACILITY REPRESENTATIVE, PATIENT EXPERIENCED CARDIAC EVENTS DURING THE PRE-OP AREA AND REVISION SURGERY DID NOT TAKE PLACE. AT THIS TIME, IT IS UNKNOWN IF THE PATIENT WILL UNDERGO REVISION SURGERY. ADDITIONAL INFORMATION RECEIVED ON 12/30/2022: THE REVISION SURGERY THAT WAS TO TAKE PLACE ON (B)(6) 2022, WAS CANCELLED DUE TO CARDIAC CO-MORBIDITIES. NO FURTHER INFORMATION HAS BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    762972 UNIVERS VAULTLOCK GLENOID, SMALL PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. UNIVERS VAULTLOCK GLENOID, SMALL 1027261845 00888867239319

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown AR-9301-03, AR-9301-43CPC, AR-9343-16