BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC

    MDR report key: 16531000 · Received March 13, 2023

    Report

    Report Number
    1038671-2023-00426
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    November 1, 2022
    Report Date
    April 1, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862272140
    PMA / PMN Number
    K150890
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE BY ADVITA AND THIS REPORT MAY BE DISREGARDED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 02-010-06-0340 - LOGIC CC FEMORAL SIZE 4, RIGHT; 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM; 200-02-35 - THREE PEG PATELLA 35MM.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT (POST-OP) THE 54 YO WHITE MALE PATIENT EXPERIENCED PAIN IN THE RIGHT KNEE DUE TO INFECTION. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    88844 OPTETRAK LOGIC PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. UNK UNK 10885862272140

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Male Other| R SEE H10.