BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GLENOID, PE WITH PEG, SMALL

    MDR report key: 15914550 · Received December 5, 2022

    Report

    Report Number
    1220246-2022-05873
    Event Type
    Injury
    Date Received
    December 5, 2022
    Date of Event
    November 11, 2022
    Report Date
    December 18, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    KWS
    PMA / PMN Number
    K083435
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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

    ADDITIONAL INFORMATION: THE COMPLAINT ALLEGATION IS CONFIRMED. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. DFU-0131-6 REV. 0 STATES THE FOLLOWING: "3. FAILURE TO ACHIEVE THE APPROPRIATE TORQUE REQUIREMENTS WHEN TIGHTENING LOCKING SCREWS MAY RESULT IN THE PREMATURE LOOSENING OF THE DEVICE."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS REQUIRED DUE TO AN ASEPTIC LOOSENING OF AN IMPLANT POST OP. A REVISION TO AN INVERSE PROSTHESIS WAS PERFORMED ON THE PATIENT. NO FURTHER INFORMATION PROVIDED.

    Description of Event or Problem · 0

    UPDATE AVOE 29-NOV-2022 IT WAS FURTHER REPORTED THAT A SHOULDER PROSTHESIS CHANGE TO INVERSE SHOULDER PROSTHESIS WAS PERFORMED AND THE AFFECTED DEVICE IS AR-9105-01 (LOT: 1427016).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1045337 GLENOID, PE WITH PEG, SMALL PROSTHESIS, SHOULDER, CEMENTED KWS ARTHREX, INC. AR-9105-01 1427016

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other