BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB FIT TRAY CEM SZ 4F / 3T

    MDR report key: 21143383 · Received January 13, 2025

    Report

    Report Number
    1038671-2025-00213
    Event Type
    Injury
    Date Received
    January 13, 2025
    Date of Event
    September 13, 2022
    Report Date
    June 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305879
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE CAUSE OF THE PATIENT¿S INFECTION/SEPTIC LOOSENING AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED. HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THERE IS NO CLINICAL/PATIENT MEDICAL INFORMATION PROVIDED. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. B3: CORRECTED. H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICES: 6264444 - 02-010-04-0240 - LOGIC CR FEMORAL POR, LEFT, SZ 4; 4141935 - 02-012-51-4013 - LOGIC TIB INSERT IMPL CRC, SZ 4, 13MM; 6529350 - 200-02-32 - THREE PEG PATELLA 32MM. THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY AND THEN APPROXIMATELY 1 YEAR, 9 MONTHS LATER, THE PATIENT EXPERIENCED A REVISION SURGICAL PROCEDURE. THE PATIENT WAS REVISED TO A COMPETITOR'S DEVICES. REVISION OPERATIVE REPORT STATES- FAILED TKA SECONDARY SEPTIC LOOSENING. X-RAYS DEMONSTRATED LOOSENING OF TIBIAL AS WELL AS PATELLAR COMPONENT. ASPIRATED KNEE, IT WAS SIGNIFICANT FOR RED BLOOD CELLS AS WELL AS 12,000 WHITE BLOOD CELLS WITH 100% NEUTROPHIL DIFFERENTIAL- NOTHING GREW FROM THE ASPIRATION. PATELLAR COMPONENT WAS COMPLETELY LOOSE. REMOVED ANY REMAINING CEMENT. FEMORAL COMPONENT WAS GROSSLY LOOSE.... REMOVED THE TIBIAL COMPONENT, IT WAS GROSSLY LOOSE. NO APPARENT COMPLICATIONS NOTED. THERE IS NO CLINICAL/PATIENT MEDICAL INFORMATION PROVIDED. NO DEVICE RETURN ANTICIPATED DUE TO THIS BEING A LEGAL CASE AND NO OTHER INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178539 TRULIANT TIB FIT TRAY CEM SZ 4F / 3T PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862305879

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Female Hospitalization SEE H11