BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN KNEE TIBIAL TRAY

    MDR report key: 8500850 · Received April 10, 2019

    Report

    Report Number
    1818910-2019-90341
    Event Type
    Injury
    Date Received
    April 10, 2019
    Date of Event
    March 21, 2019
    Report Date
    March 20, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 18189
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). THIS PRODUCT WAS REPORTED IN ERROR. NO PATIENT DEATH, SERIOUS INJURY OR EVIDENCE OF REPORTABLE PRODUCT MALFUNCTION OCCURRED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    (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

    A TC3 IN-SITU FOR 7+ YEARS WAS REVISED DUE TO LOOSE TIBIAL AND FEMORAL IMPLANTS. THE TC3 WAS RE-REVISED TO AN ATTUNE REVISION. DURING THE CASE, THE SURGEON INFORMED JJM REP AND (B)(4) (DEPUY SYNTHES) THAT HE WANTED TO CEMENT THE FEMORAL PRESS-FIT STEM (151322110) AND CEMENT A FULLY COATED TIBIAL SLEEVE (151111202). AS BOTH THESE IMPLANTS ARE INTENDED AS OFF LICENSE WE TOLD THE SURGEON THAT THIS WOULD BE OFF LICENSE AND THEREFORE NOT RECOMMENDED. DESPITE THIS ADVICE, THE IMPLANTS WERE CEMENTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    293666 UNKNOWN KNEE TIBIAL TRAY KNEE TIBIAL TRAY JWH DEPUY ORTHOPAEDICS, INC. 18189 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention