BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE KNEE TIBIAL TRAY

    MDR report key: 11243447 · Received January 28, 2021

    Report

    Report Number
    1818910-2021-01970
    Event Type
    Injury
    Date Received
    January 28, 2021
    Date of Event
    January 26, 2020
    Report Date
    January 14, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY - NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION MAY BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT - PRODUCT/LOT INFORMATION IS NOT AVAILABLE.

    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

    LITERATURE ARTICLE ENTITLED, ¿IMPLANT INTERFACE DEBONDING AFTER TOTAL KNEE ARTHROPLASTY: A NEW CAUSE FOR CONCERN?¿ BY ALEX SADAUSKAS, MD, ET AL, PUBLISHED BY ARTHROPLASTY TODAY (2020), VOL. 6, PP. 972-975, WAS REVIEWED. THIS CASE SERIES INVESTIGATES COMMONALITIES BETWEEN 9 PATIENTS WHO UNDERWENT REVISION TKA AND WERE FOUND TO HAVE COMPLETE DEBONDING AT THE CEMENT-IMPLANT INTERFACE OF A FEMORAL AND/OR TIBIAL COMPONENT IN 9 PATIENTS REVISED BETWEEN DECEMBER 2017 AND SEPTEMBER 2019. EIGHT OF THE 9 PATIENT STUDIES RECEIVED A REVISION OF A COMPETITOR KNEE CONSTRUCT. THIS COMPLAINT ILL CAPTURE PATIENT 8, THE ONLY PATIENT WITH A DEPUY KNEE CONSTRUCT. THE AUTHORS NOTE THAT ALL PATIENT PRESENTED WITH KNEE PAIN PRIOR TO REVISION. DEPUY PRODUCTS: PRIMARY ATTUNE TOTAL KNEE ARTHROPLASTY INCLUDING A FEMORAL COMPONENT, POLYETHYLENE TIBIAL COMPONENT, AND TIBIAL TRAY. THERE WAS NO INDICATION THAT THE PATELLA WAS RESURFACED, AND THE CEMENT UTILIZED IS UNKNOWN. RESULTS: PATIENT 8 RECEIVED A REVISION TO TREAT PAIN SECONDARY TO TIBIAL TRAY LOOSENING. UPON ENTERING THE JOINT, THE TIBIAL TRAY WAS LOOSENED AND DEBONDED AT THE CEMENT TO IMPLANT INTERFACE AND REVISED. THERE WAS NO REPORTED PRODUCT PROBLEM WITH THE REVISED TIBIAL INSERT. THERE IS NO INDICATION THAT THE FEMORAL COMPONENT WAS REVISED, AND THE REVISION PRODUCTS ARE UNKNOWN. CAPTURED IN THIS COMPLAINT: TIBIAL TRAY REVISION DUE TO PAIN AND IMPLANT LOOSENING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140445 UNK ATTUNE KNEE TIBIAL TRAY TIBIAL TRAY NJL DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention