BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DEPUY ATTUNE KNEE SYSTEM

    MDR report key: 8032545 · Received November 1, 2018

    Report

    Report Number
    MW5081004
    Event Type
    Injury
    Date Received
    November 1, 2018
    Date of Event
    June 8, 2015
    Report Date
    October 30, 2018
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CLIENT RECEIVED A DEPUY ATTUNE MEDICAL DEVICE FOR R KNEE TKA ON (B)(6) 2018 PERSISTENT PROBLEMS THEREAFTER WITH KNEE. UNDERWENT REPLACEMENT TKA ON (B)(6) 2018 AND ORTHOPEDIC SURGEON REPORTED NON-ADHERENCE OF THE GLUE USED TO CEMENT TIBIAL TO DEVICE RESULTING IN NEED FOR ANOTHER TKA. REPORTED THAT CEMENT WAS SITTING LOOSE BEHIND THE KNEE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    868587 DEPUY ATTUNE KNEE SYSTEM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL JWH DEPUY ORTHOPAEDICS, INC.
    868588 DEPUY ATTUNE KNEE SYSTEM PROSTHESIS, KNEE PATELLOFEMOROTIBIAL JWH DEPUY ORTHOPAEDICS, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization| S