BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3.5 9MM

    MDR report key: 17164934 · Received June 20, 2023

    Report

    Report Number
    1038671-2023-01403
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 25, 2023
    Report Date
    February 10, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304346
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): CONCOMITANTS: 4060079: 200-02-35 - THREE PEG PATELLA 35MM. 5037097: 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T. 5099910: 02-020-11-0235 - TRULIANT PS CEM FEM PS CEM LEFT SZ 3.5. 5100605: 02-022-35-3509 - TRULIANT TIB IMP PS INSERT SZ 3.5 9MM.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS, AND INSTABILITY. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR, OSTEOLYSIS, AND INSTABILITY COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES OF THE PATELLA AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR, OSTEOLYSIS AND INSTABILITY. THE REPORTED WEAR COULD NOT BE CONFIRMED FOR THE PATELLA COMPONENT, AND THE PROVIDED IMAGES OF THE TIBIAL INSERT APPEAR UNREMARKABLE WITH RESPECT TO WEAR. POSSIBLE CAUSES FOR THE INSTABILITY MIGHT INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, IMPROPER POSITIONING OF THE IMPLANTS, OR INADEQUATE SOFT TISSUE BALANCING. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR, OSTEOLYSIS, AND INSTABILITY COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND IMAGES OF THE PATELLA AND RADIOGRAPHS WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL LEFT TKA, THIS 59 Y/O MALE PATIENT WAS REVISED DUE TO INSTABILITY. FEMUR, LINER AND PATELLA WERE EXCHANGED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO X-RAYS PROVIDED, UNABLE TO OBTAIN. NO PRODUCT RETURN - WITH LAWYER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    462911 TRULIANT TIB IMP PS INSERT SZ 3.5 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862304346

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Male SEE H10.