BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM RIGHT SZ 3

    MDR report key: 20025076 · Received August 22, 2024

    Report

    Report Number
    1038671-2024-02917
    Event Type
    Injury
    Date Received
    August 22, 2024
    Date of Event
    July 29, 2024
    Report Date
    July 15, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314543
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED AND ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H4, H5. THE FOLLOWING SECTIONS WERE UPDATED: B2, B5, B7, D4 EXPIRATION DATE, G2, G3, H4, H6 CLINICAL CODES, COMPONENT CODES AND ALL INVESTIGATION CODES. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION. (D10) CONCOMITANT DEVICE(S): 5071854 02-022-45-3020 - TRULIANT TIB FIT TRAY CEM SZ 3F / 2T; 5332300 200-07-32 - ADVANCED PATELLA 32MM 3 PEG IMPLANT.

    Additional Manufacturer Narrative · 0

    THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF FEMORAL LOOSENING, INSTABILITY, OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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. THE ALLEGED WEAR OF THE TIBIAL INSERT COULD NOT BE CONFIRMED FROM THE PROVIDED IMAGE AND RADIOGRAPH. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL INFORMATION WERE NOT PROVIDED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, AND INVESTIGATION CLINICAL CODES. H10: 1038671-2025-02147, 1038671-2025-02146, 1038671-2024-01195.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 76 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, PAIN, STIFFNESS, SWELLING, DISCOMFORT, WEAKNESS AND INSTABILITY. POST OPERATIVE DIAGNOSIS NOTED WEAR AND LOOSENING OF THE IMPLANT. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS 74 Y/O FEMALE PATIENT'S RIGHT KNEE WAS REVISED APPROXIMATELY 6 YEARS 3 MONTHS POST OP. PATIENT COMPLAINED OF PAIN. PATIENT HAD LOOSE FEMUR AND RECALLED POLY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2286665 TRULIANT PS CEM FEM PS CEM RIGHT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314543

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Female Required Intervention| H SEE H11