BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CR PLUS TIB BEARING, VIT E, SZ 1, 9MM

    MDR report key: 19289005 · Received May 10, 2024

    Report

    Report Number
    1220246-2024-03119
    Event Type
    Malfunction
    Date Received
    May 10, 2024
    Date of Event
    April 5, 2021
    Report Date
    May 10, 2024
    Manufacturer
    ARTHREX, INC.
    Product Code
    MBH
    UDI-DI
    00888867231078
    PMA / PMN Number
    K171365
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, 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. 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 ERROR DUE TO MISALIGNED INSERTION.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT POLY WOULD NOT SEAT ONTO THE BASEPLATE CORRECTLY. THE SURGEON TRIED IT WITH 2 IMPLANTS WITH DIFFERENT LOT NUMBERS MULTIPLE TIMES AND NEITHER ONE WORKED. THE SURGEON USED A SIZE 10 AND THAT IMPLANT SNAPPED INTO PLACE, WITHOUT ISSUE. ADDITIONAL INFORMATION 4/13/2021 IT WAS REPORTED THAT DURING A KNEE PROCEDURE, THE AR-523-A109, POLY WOULD NOT SEAT ONTO THE BASEPLATE CORRECTLY. THE SURGEON TRIED IT WITH 2 IMPLANTS WITH DIFFERENT LOT NUMBERS MULTIPLE TIMES AND NEITHER ONE WORKED. THE CASE WAS COMPLETED USING AR-523-A210.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2498718 CR PLUS TIB BEARING, VIT E, SZ 1, 9MM KNEE PROSTHESIS PAT/FEM/TIB MBH ARTHREX, INC. CR PLUS TIB BEARING, VIT E, SZ 1, 9MM 579202224 00888867231078

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown