BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 2

    MDR report key: 17164994 · Received June 20, 2023

    Report

    Report Number
    1038671-2023-01404
    Event Type
    Injury
    Date Received
    June 20, 2023
    Date of Event
    May 26, 2023
    Report Date
    August 24, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314529
    PMA / PMN Number
    K170240
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION (D10) CONCOMITANT DEVICE(S): 5230543 02-022-35-2009 - TRULIANT TIB IMP PS INSERT SZ 2 9MM 5248479 02-022-45-2020 - TRULIANT TIB FIT TRAY CEM SZ 2F / 2T. 5202522 200-07-29 - ADVANCED PATELLA 29M 3 PEG IMPLANT.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE AND/OR PATIENT RELATED CONDITIONS, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT TKA, THIS 39 Y/O FEMALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT COMPLAINED OF PAIN. DUE TO RECALL SURGEON USED COMPETITOR DEVICES FOR REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. UNKNOWN MEDICAL HISTORY. PRODUCT IS NOT BEING RETURNED - DUE TO RECALL HOSPITAL WILL NOT RELEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    647154 TRULIANT PS CEM FEM PS CEM RIGHT SZ 2 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862314529

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Female SEE H10.