BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNKNOWN KNEE TIBIAL INSERT

    MDR report key: 11532057 · Received March 19, 2021

    Report

    Report Number
    1818910-2021-05630
    Event Type
    Malfunction
    Date Received
    March 19, 2021
    Date of Event
    January 1, 2021
    Report Date
    March 2, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DURING A TRIAL FOR REVISION ATTUNE, THE INSERT LOOSENS FROM THE TRIAL TIBIAL BASE AND THIS DOES NOT ALLOW TO DO OUR TRIALS PROPERLY. THE CHOICE OF PE IS THEN MADE MORE OR LESS RANDOMLY BECAUSE WE ONLY HAVE A REAL TEST WITH THE FINAL PROSTHESIS ON WHICH THE CHANGE OF PE IS MORE DIFFICULT TO PERFORM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    427242 UNKNOWN KNEE TIBIAL INSERT KNEE TIBIAL INSERT JWH DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1