BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 19574975 · Received June 20, 2024

    Report

    Report Number
    1038671-2024-02039
    Event Type
    Injury
    Date Received
    June 20, 2024
    Date of Event
    March 27, 2023
    Report Date
    October 22, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314550
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    RELATED: MFR #1038671-2024-01935 REPORT 1 OF 2. ADDITIONAL MANUFACTURER NARRATIVE- REPORT 2 OF 2. D10. 2523700, 02-012-44-3511 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 3.5, 11MM & 6163506, 02-012-45-3535 - LGC TIBIAL FIT TRAY CEM SZ 3.5F / 3.5T. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. THERE IS NO ADDITIONAL INFORMATION AVAILABLE. PENDING INVESTIGATION.

    Additional Manufacturer Narrative · 0

    H6: CORRECTED THE FOLLOWING: TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT THE PATIENT WAS IMPLANTED WITH AN OPTETRAK LOGIC DEVICE ON THE RIGHT KNEE AND THEN APPROXIMATELY 3 YEARS, 3 MONTHS LATER THE PATIENT WAS REVISED. IT IS STATED THE PATIENT HAS SUFFERED THE FOLLOWING INJURIES AND COMPLICATIONS: JOINT PAIN, JOINT SWELLING AND STIFFNESS, TISSUE DAMAGE, REVISION SURGERY, LOOSENING, POLYETHYLENE WEAR, OSTEOLYSIS, SYNOVITIS, IMPLANT-INTERFACE DEBONDING, GENICULATE ARTERY EMBOLIZATION, PATELLAR LATERAL FACETECTOMY. THERE WAS NO OTHER PATIENT/MEDICAL INFORMATION PROVIDED. NO X-RAYS OR IMAGES WERE PROVIDED. THERE IS NO DEVICE RETURN. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1511114 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314550

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11