BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK ATTUNE KNEE TIBIAL TRAY

    MDR report key: 11440662 · Received March 8, 2021

    Report

    Report Number
    1818910-2021-04648
    Event Type
    Injury
    Date Received
    March 8, 2021
    Report Date
    February 25, 2021
    Manufacturer
    DEPUY IRELAND - 9616671
    Product Code
    NJL
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT#: (B)(4). INVESTIGATION SUMMARY: THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RECEIVED FOR EXAMINATION. DEPUY SYNTHES CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. 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 NOT AVAILABLE CORRECTED: E1 (REPORTER'S NAME).

    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

    THE LITERATURE ARTICLE "TIBIAL TRAY THICKNESS DOES NOT SIGNIFICANTLY INCREASE MEDIAL TIBIAL BONE RESORPTION: USING TIBIAL BONE DENSITY AS AN OBJECTIVE MEASUREMENT METHOD" WRITTEN BY DANIEL WAI-YIP WONG, QUNN-JID LEE, CHI-KIN LO, YIU-CHUNG WONG, KENNETH WING-KIN LAW, AND ALWIN HOK-YIN LI PUBLISHED BY THE KNEE 27 (2020) 572-579 WAS REVIEWED. HTTPS://DOI.ORG/10.1016/J.KNEE.2019.12.011. THE ARTICLE'S PURPOSE WAS TO VERIFY THE HYPOTHESIS THAT THICK TIBIAL TRAY RESULTS IN STRESS SHIELDING AND INCREASES THE RISK OF BONE RESORPTION AND TO OBJECTIVELY QUANTIFY MEDIAL TIBIAL DENSITY BY USING SERIAL MEASUREMENTS WITH DIGITAL RADIOLOGICAL DENSITOMETRY. FINDINGS WERE MEDIAL TIBIAL BONE DENSITY OF THE THICK-TRAY COHORT WAS SIGNIFICANTLY HIGHER THAN THE THIN-TRAY COHORT AT ONE YEAR BUT NOT AT 2 OR 3 YEARS. IT IS NOTED THAT THE TIBIAL TRAY UNDER STUDY IN THE THICK TRAY GROUP ARE DEPUY ATTUNE TIBIAL TRAYS AND THE OTHER GROUP IS NON DEPUY TIBIAL TRAYS. CEMENT MANUFACTURER IS NOT IDENTIFIED AND PATELLAR RESURFACING IS NOT DISCUSSED. FIGURE 3 AND 4 PROVIDES RADIOGRAPHIC IMAGES WITHOUT IMPLANT IDENTIFICATION AND NO ADVERSE EVENTS IN CAPTION DESCRIPTIONS. DEPUY PRODUCTS: ATTUNE FEMORAL, ATTUNE INSERT, ATTUNE TIBIAL TRAY. ADVERSE EVENTS: MEDIAL TIBIAL BONE RESORPTION AND BONE LOSS ASSOCIATED WITH TIBIAL TRAY (NO TREATMENT PROVIDED/NO REVISION - NO FURTHER INFORMATION PROVIDED REGARDING PATIENT EXPERIENCE) PATELLAR CLUNK SYNDROME (NO TREATMENT PROVIDED/NO REVISION - NO FURTHER INFORMATION PROVIDED REGARDING PATIENT EXPERIENCE). STIFFNESS REQUIRING MANIPULATION UNDER ANESTHESIA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    330247 UNK ATTUNE KNEE TIBIAL TRAY KNEE TIBIAL TRAY NJL DEPUY IRELAND - 9616671

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention