BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM LEFT SZ 4

    MDR report key: 15494195 · Received September 27, 2022

    Report

    Report Number
    1038671-2022-01174
    Event Type
    Injury
    Date Received
    September 27, 2022
    Date of Event
    September 1, 2022
    Report Date
    March 2, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314451
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT DEVICE(S): S035099, 02-022-35-4009 - TRULIANT TIB IMP PS INSERT SZ 4 9MM; 6222387, 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T; 6190986, 200-07-35 - ADVANCED PATELLA 35MM 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, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND PAIN. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3 YEARS POST OP THE INITIAL LEFT TKA, THIS 75 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR. PATIENT COMPLAINED OF PAIN. DUE TO RECALL SURGEON USED A COMPETITOR FOR REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. PRODUCT NOT RETURNING, DUE TO RECALL HOSPITAL WILL NOT RELEASE THE IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2304271 TRULIANT PS CEM FEM PS CEM LEFT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-020-11-0240 UNK 10885862314451

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male Required Intervention