BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS STD SZ 4, 15MM

    MDR report key: 15546387 · Received October 5, 2022

    Report

    Report Number
    1038671-2022-01253
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    September 14, 2022
    Report Date
    April 6, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306500
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) NON COMPLAINT. PER CFR 21, 803.22, IT IS DETERMINED THAT THE INFORMATION RECEIVED/LEGAL JARGON IS NOT RELATED TO AN ADVERSE EVENT FOR THIS PARTICULAR DEVICE. IF ANY INFORMATION IS RECEIVED THAT INDICATES AN ADVERSE EVENT HAS OCCURRED DUE TO THIS DEVICE THE CASE/COMPLAINT WILL BE REOPENED AND APPROPRIATELY INVESTIGATED. THE ACTUAL COMPLAINT FROM THE LEGAL FILE IS APPROPRIATELY CAPTURED IN (B)(4).

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 02-020-13-0240 - TRULIANT CR CEM FEM CR CEM LEFT SZ 4 6519329, 02-022-45-4050 - TRULIANT TIB FIT TRAY CEM SZ 4F / 5T 5954886, 200-02-35 - THREE PEG PATELLA 35MM 6003772.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS MALE PATIENT'S LEFT KNEE WAS REVISED 2 YEARS POST OP DUE TO DAILY PAIN AND DISCOMFORT WHICH LIMITS HIS ACTIVITIES OF DAILY LIVING AND IMPACTS HIS QUALITY OF LIFE. FOLLOWING REVISION SURGERY, PATIENT IS CONTINUES TO BE LIMITED IN HIS ACTIVITIES OF DAILY LIVING. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2504950 TRULIANT TIB IMP CR INS STD SZ 4, 15MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-022-47-4015 UNK 10885862306500

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10