BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRU CC FEMORAL SIZE 1 LEFT

    MDR report key: 23281615 · Received October 15, 2025

    Report

    Report Number
    1038671-2025-03090
    Event Type
    Injury
    Date Received
    October 15, 2025
    Date of Event
    May 12, 2020
    Report Date
    October 13, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K150890
    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

    CONCOMITANT PRODUCTS: TRULIANT TIB FIT TRAY CEM SZ 1F / 1T (CAT# 02-022-45-1010 / SERIAL# (B)(6), TRULIANT TIB IMP PS INSERT SZ 1 12MM (CAT# 02-022-35-1012 / SERIAL# (B)(6), LOGIC STEM EXT 14MM X 25MM (CAT# 02-012-60-1425 / SERIAL# (B)(6), LOGIC OFFSET STEM EXT COUPLER 4MM (CAT# 02-012-61-4000 / SERIAL# (B)(6), TRU FLUTED STM EXT 12MM X 80MM BLAST (CAT# 02-012-64-1280 / SERIAL# (B)(6), CC DISTAL FEM AUGMENT SZ 1, 5MM (CAT# 208-05-01 / SERIAL# (B)(6). THE REASON FOR THE REVISION CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF REPORTED FEMORAL LOOSENING AND TIBIAL SUBSIDENCE. THE FEMORAL LOOSENING AND TIBIAL SUBSIDENCE AND THE CAUSE FOR THESE COULD NOT BE CONFIRMED AS IMAGES OF THE DEVICES OR RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH CC CLINICAL STUDY, APPROXIMATELY THREE MONTHS POST INITIAL LEFT SIDE TKA, THE 63 Y/O FEMALE PATIENT EXPERIENCED TIBIAL IMPLANT SUBSIDENCE AND INCOMPLETE FIXATION OF FEMORAL COMPONENT, PROGRESSIVE PAIN AND FUNCTIONAL COMPROMISE. PATIENT HAD A REVISION ON 17-DEC-2020 OF FEMORAL, TIBIAL INSERT, TIBIAL TRAY COMPONENTS. CONCOMITANT PRODUCTS: TRULIANT TIB FIT TRAY CEM SZ 1F / 1T (CAT# 02-022-45-1010 / SERIAL# (B)(6), LOGIC CC FEMORAL SIZE 1, LEFT (CAT# 02-010-06-0210 / SERIAL# (B)(6), LOGIC STEM EXT 14MM X 25MM (CAT# 02-012-60-1425 / SERIAL# (B)(60, LOGIC OFFSET STEM EXT COUPLER 4MM (CAT# 02-012-61-4000 / SERIAL# (B)(6), TRU FLUTED STM EXT 12MM X 80MM BLAST (CAT# 02-012-64-1280 / SERIAL# (B)(6), CC DISTAL FEM AUGMENT SZ 1, 5MM (CAT# 208-05-01 / SERIAL# (B)(6). (B)(6) 02-022-35-1012 - TRULIANT TIB IMP PS INSERT SZ 1 12MM. SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. 510K: K171045.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2596764 TRU CC FEMORAL SIZE 1 LEFT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Female Hospitalization| R SEE H10