BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CR PLUS TIB BEARING, VIT E, SZ 7, 14MM

    MDR report key: 19567431 · Received June 19, 2024

    Report

    Report Number
    1220246-2024-06112
    Event Type
    Malfunction
    Date Received
    June 19, 2024
    Date of Event
    October 6, 2022
    Report Date
    June 19, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBH
    UDI-DI
    00888867231849
    PMA / PMN Number
    K171365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    501

    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. THE COMPLAINT DEVICE WAS NOT RECEIVED FOR EVALUATION. BASED OFF THE INFORMATION PROVIDED, THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO USER-APPLIED EXCESSIVE MECHANICAL FORCES.

    Description of Event or Problem · 0

    ON 10/11/2022, IT WAS REPORTED BY A SALES REPRESENTATIVE VIA PHONE THAT AN AR-523-A714 CR PLUS TIB BEARING IMPLANT HAD AN ISSUE. DURING A TOTAL KNEE ARTHROPLASTY PROCEDURE ON 10/6/2022, WHEN THE SURGEON WAS TRYING TO USE THE DEVICE, THE DEVICE FAILED TO ENGAGE IN THE TIBIAL TRAY, IT WOULD NOT LOCK, AND THE PERIPHERAL LOCKING MECHANISM WOULD NOT ENGAGE. THE SURGEON REMOVED THE COMPLAINT DEVICE FROM THE PATIENT, IT WAS REMOVED IN ONE PIECE AND NO PIECE OF THE INSTRUMENT BROKE INSIDE THE PATIENT. UPON INVESTIGATION, IT WAS STATED THAT THE PERIPHERAL POLY WAS BENT/DEFORMED. THE SURGEON USED ANOTHER AR-523-A714, LOT NUMBER UNKNOWN TO COMPLETE THE CASE SUCCESSFULLY WITH NO IMPACT TO THE PATIENT. THE COMPLAINT DEVICE WAS DISCARDED BY THE FACILITY. IT WAS STATED THAT THIS MIGHT HAVE HAPPENED AS AN OUT-OF-BOX EVENT, BUT IT COULD NOT BE VERIFIED AS NO PICTURES WERE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    550061 CR PLUS TIB BEARING, VIT E, SZ 7, 14MM KNEE PROSTHESIS PAT/FEM/TIB MBH ARTHREX, INC. CR PLUS TIB BEARING, VIT E, SZ 7, 14MM 579202441 00888867231849

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown