BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OPTETRAK LOGIC KNEE COMPONENTS

    MDR report key: 16599755 · Received March 23, 2023

    Report

    Report Number
    1038671-2023-00493
    Event Type
    Injury
    Date Received
    March 23, 2023
    Date of Event
    June 1, 2017
    Report Date
    May 7, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862173669
    PMA / PMN Number
    K110547
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANTS: 06001016009, A10012 - GPS IMPLANT KIT V2; SERIAL #: (B)(4), CATEGORY #: 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T; SERIAL #: (B)(4), CATEGORY #: 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM; SERIAL #: (B)(4), CATEGORY #: 02-012-60-2080 - LOGIC STEM EXT 20MM X 80MM; SERIAL #: (B)(4), CATEGORY #: 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM; SERIAL #: (B)(4), CATEGORY #: 02-010-06-0541 - LOGIC POST. AUG. BLOCK SIZE 4, 5MM; SERIAL #: (B)(4), CATEGORY #: 204-70-00 - TIBIAL STEM EXT. SCREW; SERIAL #: (B)(4), CATEGORY #: 208-06-04 - CC DISTAL FEM AUGMENT SZ 4, 10MM; SERIAL #: (B)(4), CATEGORY #: 02-010-06-0240 - LOGIC CC FEMORAL SIZE 4, LEFT; SERIAL #: (B)(4), CATEGORY #: 02-012-61-2000 - LOGIC OFFSET STEM EXT COUPLER 2MM; SERIAL #: (B)(4), CATEGORY #: 02-012-60-1440 - LOGIC STEM EXT 14MM X 40MM; SERIAL #: (B)(4), CATEGORY #: 02-012-66-2000 - METAPHYSEAL TIBIAL CONE, ML32MM.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDY, THAT THE 62 YO MALE PATIENT EXPERIENCED ARTHROFIBROSIS AND PATELLAR CLUNK RESULTING IN PAINFUL CATCHING AND CLICKING IN THE L KNEE. THE DATE OF ADVERSE EVENT ONSET IS (B)(6) 2017. THE PATIENT WAS TREATED WITH PHYSICAL THERAPY AND BRACING. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS RESOLVED ON (B)(6) 2018.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311530 OPTETRAK LOGIC KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. UNK UNK 10885862173669

    Patients

    Seq Age Sex Outcome Treatment
    1