BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE COMPONENTS

    MDR report key: 16535096 · Received March 13, 2023

    Report

    Report Number
    1038671-2023-00430
    Event Type
    Injury
    Date Received
    March 13, 2023
    Date of Event
    January 1, 2023
    Report Date
    October 28, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862265678
    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

    AFTER FURTHER INVESTIGATION, IT WAS NOTED THAT THERE WAS NO SERIOUS INJURY DUE TO INFECTION. A REVISION WAS NOT COMPLETED. THE PATIENT HAS A HISTORY OF INFECTION, HOWEVER, WHAT THEY ARE REPORTING IS THE STIFFNESS OF LEFT KNEE AND THEREFORE NOT REPORTABLE. THIS MDR SUBMISSION IS BEING RESCINDED.

    Additional Manufacturer Narrative · 0

    CONCOMITANT MEDICAL PRODUCTS: 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T; 02-012-64-2016 - TRU FLUTED STM EXT 20MM X 160MM BLAST; 02-012-61-6000 - LOGIC OFFSET STEM EXT COUPLER 6MM; 200-02-35 - THREE PEG PATELLA 35MM; 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM; 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM; 02-012-66-5000 - METAPHYSEAL TIBIAL CONE, ML57MM.

    Description of Event or Problem · 0

    STUDY: EXACTECH CC CLINICAL STUDY; SUBJECT: (B)(6). IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 66 YO MALE PATIENT EXPERIENCED STIFFNESS OF LEFT KNEE. THE DATE OF ONSET IS UNKNOWN. THE PATIENT UNDERWENT REVISION SURGERY DUE TO THE INFECTION. THE PATIENT WAS ALSO TREATED WITH MEDICATION AND PHYSICAL THERAPY. 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. 02-010-06-0240 - LOGIC CC FEMORAL SIZE 4, LEFT, 510K: K150890. CONCOMITANT MEDICAL PRODUCTS: 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T; 02-012-64-2016 - TRU FLUTED STM EXT 20MM X 160MM BLAST; 02-012-61-6000 - LOGIC OFFSET STEM EXT COUPLER 6MM; 200-02-35 - THREE PEG PATELLA 35MM; 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM; 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM; 02-012-66-5000 - METAPHYSEAL TIBIAL CONE, ML57MM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    711703 LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862265678

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Male Other| R SEE H10.