BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 11MM

    MDR report key: 15848567 · Received November 22, 2022

    Report

    Report Number
    1038671-2022-01499
    Event Type
    Injury
    Date Received
    November 22, 2022
    Date of Event
    October 27, 2022
    Report Date
    February 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304278
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H3: 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 PAIN AND THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO PATIENT CONDITIONS AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, BILATERAL KNEE REPLACEMENTS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. D10: 6608367, 02-010-06-0230 - LOGIC CC FEMORAL SIZE 3, LEFT; 5777187, 02-012-50-3011 - LOGIC FIT/RBK AUGMENT 1/2 BLOCK SZ 3, 5MM; 6571844, 02-012-61-2000 - LOGIC OFFSET STEM EXT COUPLER 2MM; 6806530, 02-012-61-2000 - LOGIC OFFSET STEM EXT COUPLER 2MM; 5738393, 02-012-64-1280 - TRU FLUTED STM EXT 12MM X 80MM BLAST; 5642075, 02-012-64-1412 - TRU FLUTED STM EXT 14MM X120MM BLAST; 7021049, 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T; 6605756, 204-70-00 - TIBIAL STEM EXT. SCREW; 7004345, 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM; 7004348, 208-05-03 - CC DISTAL FEM AUGMENT SZ 3, 5MM.

    Description of Event or Problem · 0

    AS REPORTED, THIS MALE PATIENT HAD AN INITIAL LEFT TKA ON (B)(6) 2021. THE SURGEON PERFORMED A POLY SWAP ON A LOGIC CC KNEE. THE PATIENT WAS COMPLAINING OF PAIN. THERE WAS NO BREAKAGE OF DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413325 TRULIANT TIB IMP PS INSERT SZ 3 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-022-35-3011 10885862304278

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention SEE H10.| SEE H10.