BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC KNEE COMPONENTS

    MDR report key: 20522467 · Received October 24, 2024

    Report

    Report Number
    1038671-2024-04105
    Event Type
    Injury
    Date Received
    October 24, 2024
    Date of Event
    November 1, 2017
    Report Date
    October 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 02-010-06-0240 - TRU CC FEMORAL SIZE 4 LEFT: 4798194, 02-012-35-4017 - LOGIC PS TIB INS SZ 4 17MM: 2916041, 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T: 2046914, 02-012-60-1480 - TRU STEM EXT 14MM X 80MM: 4562441, 02-012-61-4000 - TRU OFFSET STEM EXT COUPLER, 4MM: 4690545, 02-012-60-2080 - TRU STEM EXT 20MM X 80MM: 4539233, 02-012-61-4000 - TRU OFFSET STEM EXT COUPLER, 4MM: 5014271, 02-010-06-0541 - TRU POST. AUG. SIZE 4, 5MM: 4694401, 208-05-04 - CC DISTAL FEM AUGMENT SZ 4, 5MM: 3984131, 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM: 4536864.

    Description of Event or Problem · 0

    APPROXIMATELY 5 DAY(S) POST-OPERATIVE OF A REVISED LEFT TKA OF A COMPETITOR'S PRODUCT, IT WAS REPORTED VIA CLINICAL STUDY THAT THE PATIENT EXPERIENCED A SUTURE REACTION - LOCALIZED SKIN SUTURE REACTION WITH SLIGHT DRAINAGE. THE PATIENT WAS GIVEN MEDICATION AND LOCAL WOUND CARE AND THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. THE CLINICAL REPORT INDICATES THAT THIS EVENT IS DEFINITELY NOT RELATED TO THE DEVICE(S) AND POSSIBLY RELATED TO THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1772584 OPTETRAK LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male Other SEE H11