BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LOGIC KNEE SYSTEM

    MDR report key: 15253511 · Received August 18, 2022

    Report

    Report Number
    1038671-2022-00939
    Event Type
    Injury
    Date Received
    August 18, 2022
    Date of Event
    February 23, 2021
    Report Date
    October 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305114
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL DEVICES: 02-010-06-0230 - LOGIC CC FEMORAL SIZE 3, LEFT, 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T, 02-012-61-2000 - LOGIC OFFSET STEM EXT COUPLER 2MM, 02-012-61-6000 - LOGIC OFFSET STEM EXT COUPLER 6MM.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA CLINICAL STUDIES, EXACTECH TRULIANT KNEE CLINICAL STUDY, THAT A 67 YO FEMALE PATIENT, WHO HAD A LEFT KNEE REVISION ON (B)(6) 2020 FOLLOWING A POST TRAUMATIC EVENT, ¿SUBJECT PUT KNEE INTO VALGUS WHILE DOING YOGA¿, THEN HAD A SPACER IMPLANTED ON (B)(6) 2020, HAD A REVISION OF THEIR TOTAL KNEE ON (B)(6) 2020. ALSO NOTED, THERE WAS RESIDUAL FLUID AT THE WOUND SITE, DATE OF ONSET (B)(6) 2020 WHICH WAS ASPIRATED AND A CORTISONE INJECTION WAS ADMINISTERED ON (B)(6) 2021. LEFT KNEE ASPIRATED ALSO ON (B)(6) 2021. THE CASE REPORT DOES NOT INDICATE IF THIS WAS RELATED TO DEVICES OR PROCEDURE. OUTCOME INDICATES CONTINUING. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AND ACTIVITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2244921 LOGIC KNEE SYSTEM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. TRULIANT TIB IMP PSC INSERT SZ 3, 13MM UNK 10885862305114

    Patients

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