BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CR PLUS TIB BEARING, VIT E, SZ 7, 8MM

    MDR report key: 20953579 · Received December 17, 2024

    Report

    Report Number
    1220246-2024-08914
    Event Type
    Malfunction
    Date Received
    December 17, 2024
    Date of Event
    November 21, 2024
    Report Date
    July 10, 2025
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBH
    PMA / PMN Number
    K171365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    501

    Narratives

    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.

    Additional Manufacturer Narrative · 0

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

    Description of Event or Problem · 0

    ON (B)(6) 2024, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-523-A708 CR PLUS TIBIAL BEARING HAD AN ISSUE DURING A TOTAL KNEE ARTHROPLASTY ON (B)(6)2024. WHEN THE SURGEON IMPLANTED IT IN THE TIBIAL TRAY, THE DEVICE WOULD NOT SEAT PROPERLY. THE SURGEON REMOVED THE AR-523-A708 CR PLUS TIBIAL BEARING IN ONE PIECE; NOTHING BROKE INSIDE THE PATIENT, AND THERE WAS NO PATIENT HARM. ANOTHER R-523-A708 CR PLUS TIBIAL BEARING WITH LOT NUMBER 579202786 WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE DEVICE WAS DISCARDED, AND NO PICTURES WERE TAKEN. THERE WAS NO CASE DELAY REPORTED AND NO ADDITIONAL ANESTHESIA WAS ADMINISTERED. THIS OCCURRED DURING USE WITH NO REPORTED PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267364 CR PLUS TIB BEARING, VIT E, SZ 7, 8MM KNEE PROSTHESIS PAT/FEM/TIB MBH ARTHREX, INC. CR PLUS TIB BEARING, VIT E, SZ 7, 8MM 579202663

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown