BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CR PLUS TIB BEARING, VIT E, SZ 4, 9MM

    MDR report key: 21020957 · Received December 26, 2024

    Report

    Report Number
    1220246-2024-09062
    Event Type
    Malfunction
    Date Received
    December 26, 2024
    Date of Event
    November 26, 2024
    Report Date
    August 14, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBH
    UDI-DI
    00888867231528
    PMA / PMN Number
    K171365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: G3, H3, H6. 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 USER ERROR DUE TO MISALIGNED INSERTION AND/OR IMPROPER BONE PREPARATION.

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-523-A409 CR PLUS TIB BEARING, VIT E, SZ 4, 9MM WOULD NOT PROPERLY SEAT IN THE TIBIAL TRAY. ANOTHER OF THE SAME PRODUCT FROM THE SAME LOT WAS USED WITHOUT ISSUES. THERE WAS NO CASE DELAY. THIS WAS DISCOVERED DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2024, WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1890401 CR PLUS TIB BEARING, VIT E, SZ 4, 9MM KNEE PROSTHESIS PAT/FEM/TIB MBH ARTHREX, INC. CR PLUS TIB BEARING, VIT E, SZ 4, 9MM 579205009 00888867231528

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown