BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNIVERSAL GLENOID - INLAY LARGE PLUS

    MDR report key: 12364477 · Received August 25, 2021

    Report

    Report Number
    1220246-2021-03573
    Event Type
    Malfunction
    Date Received
    August 25, 2021
    Date of Event
    July 22, 2021
    Report Date
    November 11, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    PHX
    UDI-DI
    00888867057463
    PMA / PMN Number
    K182039
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    THE COMPLAINT IS NOT CONFIRMED. ALLEGATIONS STATES THERE WAS LOOSENING OF THE HUMERAL IMPLANTS. THE AR-9121-06 IS A GLENOID IMPLANT. DAMAGE AND ABRASION WERE OBSERVED ON THE DEVICE, THE CAUSE OF WHICH IS UNDETERMINED. NO FURTHER ABNORMALITY WAS OBSERVED ON THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE HUMERAL LOOSENING.

    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. IF THE DEVICE BECOMES AVAILABLE FOR EVALUATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A REVISION SHOULDER PROCEDURE ON (B)(6) 2021 WHERE AN ARTHREX IMPLANT WAS REMOVED. NO FURTHER DETAILS, ADDITIONAL INFORMATION HAS BEEN REQUESTED. ADDITIONAL INFORMATION PROVIDED 08/19/2021: THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2021 FOR A LEFT TOTAL SHOULDER ARTHROPLASTY. THIS PROCEDURE TOOK PLACE AT (B)(6) SURGERY CENTER, ARTHREX ACCOUNT # (B)(4). REVISION FOR A LEFT ANATOMIC TOTAL SHOULDER ARTHROPLASTY TO REVERSE SHOULDER ARTHROPLASTY TOOK PLACE AT ARTHREX ACCOUNT # (B)(4) ON (B)(6) 2021 WHERE THE FOLLOWING DEVICES WERE EXPLANTED: AR-9301-02 (20.00960); AR-9301-47CPC (19.04096); AR-9347-20 (2797, 47/20); AR-9121-06 (17.01402).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1264066 UNIVERSAL GLENOID - INLAY LARGE PLUS SHOULDER PROSTHESIS, REVERSE CONFIGURATION PHX ARTHREX, INC. UNIVERSAL GLENOID - INLAY LARGE PLUS 17.01402 00888867057463

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other