BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 6

    MDR report key: 17920035 · Received October 12, 2023

    Report

    Report Number
    1038671-2023-02514
    Event Type
    Injury
    Date Received
    October 12, 2023
    Date of Event
    September 25, 2023
    Report Date
    July 18, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314598
    PMA / PMN Number
    K170240
    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/D11: CONCOMITANT MEDICAL PRODUCTS: 4200799 200-02-41 - THREE PEG PATELLA 41MM. 5690630 02-022-45-6050 - TRULIANT TIB FIT TRAY CEM SZ 6F / 5T. M002142 02-022-35-6010 - TRULIANT TIB IMP PS INSERT SZ 6 10MM.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: H6. MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G. THE REVISION REPORTED WAS LIKELY THE RESULT OF PATELLAR PROSTHESIS WEAR AND DUE TO THE REPORTED FEMORAL LOOSENING. FAILURE OF THE CEMENT USED TO SECURE THE FEMORAL COMPONENT TO THE FEMORAL BONE, MAY HAVE LED TO LOOSENING AT THE CEMENT-IMPLANT AND/OR CEMENT-BONE INTERFACE; HOWEVER, THIS CANNOT BE CONFIRMED. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALTRACKING BETWEEN THE PATELLA AND THE FEMORAL COMPONENT, PATIENT-RELATED CONDITIONS, INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, OR ANY COMBINATION OF THESE POSSIBILITIES. AS THE SUSPECT DEVICE WAS NOT PROVIDED, THESE POTENTIAL CAUSES OR THEIR CONTRIBUTION TO THE SEQUENCE OF EVENTS CANNOT BE CONFIRMED. 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, APPROXIMATELY 5 YEARS POST OP INITIAL RIGHT TKA, THIS 75 Y/O MALE PATIENT WAS REVISED DUE TO A LOOSE FEMUR AND RECALLED POLY. PATIENT COMPLAINT OF PAIN. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1505464 TRULIANT PS CEM FEM PS CEM RIGHT SZ 6 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862314598

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Male SEE H10