BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK

    MDR report key: 12362195 · Received August 24, 2021

    Report

    Report Number
    1220246-2021-03549
    Event Type
    Malfunction
    Date Received
    August 24, 2021
    Date of Event
    July 22, 2021
    Report Date
    October 1, 2021
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    COMPLAINT NOT CONFIRMED, NO ABNORMALITY WAS OBSERVED ON THE DEVICE THAT MAY HAVE CONTRIBUTED TO THE EVENT. ONLY MINOR WEAR WAS OBSERVED THAT IS EXPECTED FROM A DEVICE THAT WAS EXPLANTED.

    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 8/19/2021: THE DATE OF THE PRIMARY PROCEDURE WAS ON (B)(6) 2021 FOR A LEFT TOTAL SHOULDER ARTHROPLASTY. THIS PROCEDURE TOOK PLACE AT GATEWAY 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
    1258217 UNK PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED KWS ARTHREX, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other