BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC

    MDR report key: 17002550 · Received May 25, 2023

    Report

    Report Number
    1038671-2023-01140
    Event Type
    Injury
    Date Received
    May 25, 2023
    Date of Event
    June 14, 2022
    Report Date
    May 25, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862266132
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D2B: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL/POLYMER. D10: CONCOMITANTS: 4948440, 02-010-06-0340 - LOGIC CC FEMORAL SIZE 4, RIGHT. 5448042, 02-012-64-1412 - TRU FLUTED STM EXT 14MM X120MM BLAST. 5560513, 02-012-64-2012 - TRU FLUTED STM EXT 20MM X120MM BLAST. 6331246, 02-022-45-4030 - TRULIANT TIB FIT TRAY CEM SZ 4F / 3T. 6371861, 200-02-38 - THREE PEG PATELLA 38MM. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA A CC CLINICAL STUDY, THAT A 65 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022. APPROXIMATELY 2 YEARS 4 MONTHS POST THE INITIAL PROCEDURE DUE TO INFECTION. THE PATIENT HAD AN INFLAMMATORY RESPONSE TO THE PROSTHESIS. POLY FAIL INDICATED. THE PATIENT WAS REVISED TO A NON EXACTECH DEVICE. THE STUDY INDICATES THE EVENT WAS DEFINITELY RELATED TO THE DEVICES AND THE PROCEDURE. THE EVENT WAS RESOLVED ON (B)(6) 2022.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    850337 LOGIC SEE H10 JWH EXACTECH, INC. LOGIC CC TIB INSERT SIZE 4, 15MM UNK 10885862266132

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10.