BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PS TIBIAL BEARING, SIZE 4, 9MM, VIT E

    MDR report key: 19154272 · Received April 22, 2024

    Report

    Report Number
    1220246-2024-02211
    Event Type
    Malfunction
    Date Received
    April 22, 2024
    Date of Event
    September 28, 2022
    Report Date
    April 22, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBH
    UDI-DI
    00888867232457
    PMA / PMN Number
    K171365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS 3500A RECORD IS SUBMITTED TO COMPLY WITH AN FDA 483 INSPECTIONAL OBSERVATION ISSUED TO ARTHREX INC ON MAY 5, 2023. ARTHREX HAS REASSESSED THE REPORTABILITY DECISIONS MADE ON HISTORICAL COMPLAINT RECORDS USING REVISED CRITERION. THIS 3500A DOCUMENT IS A RESULT OF THE REASSESSMENT. COMPLAINT NOT CONFIRMED. VISUAL EVALUATION FOUND NO PROBLEMS WITH THE COLOR OR SHAPE OF THE DEVICE. NO PROBLEM FOUND.

    Description of Event or Problem · 0

    ON 9/29/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA EMAIL THAT AN AR-523-B409 PS TIBIAL BEARING BACK SIDE WAS ROUND. SURGEON ATTEMPTED TO IMPACT THE POLY IN, WITHOUT ANY SUCCESS, AS THE SURGEON COULD EASILY LIFT IT OUT. THE POLY WOULD NOT SNAP IN. ANOTHER POLY WAS OPENED AND BOTH WERE EXAMINED PRIOR TO IMPLANTATION. THAT IS WHEN SURGEON NOTICED THE DIFFERENCE IN APPEARANCE. THE NEW POLY WAS USED TO COMPLETE THE CASE WITHOUT FURTHER ISSUES. THIS WAS DISCOVERED DURING A TOTAL KNEE PROCEDURE ON (B)(6) 2022. ADDITIONAL INFORMATION RECEIVED 10/3/2022: NOTHING BROKE INSIDE THE PATIENT AND CASE WAS COMPLETED WITH ANOTHER AR-523-B409 PS TIBIAL BEARING FROM LOT NUMBER 5791824.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1035995 PS TIBIAL BEARING, SIZE 4, 9MM, VIT E KNEE PROSTHESIS PAT/FEM/TIB MBH ARTHREX, INC. PS TIBIAL BEARING, SIZE 4, 9MM, VIT E 5791932 00888867232457

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown