BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM LEFT SZ 4

    MDR report key: 25174984 · Received May 14, 2026

    Report

    Report Number
    1038671-2026-00609
    Event Type
    Injury
    Date Received
    May 14, 2026
    Date of Event
    April 28, 2026
    Report Date
    May 14, 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
    ME, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-012-41-4040 - LOGIC TIBIA TRAPTRAY CEM SZ 4F/4T: 5770964. 02-012-44-4013 - LOGIC TIBIA IMPLANT PSC INSERT, SZ 4, 13MM: 2484094. 02-020-11-0240 - TRULIANT PS CEM FEM PS CEM LEFT SZ 4: 5528906. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT EXPERIENCED OSTEOLYSIS, POLYETHYLENE LINER WEAR AND LOOSENING OF THE FEMORAL COMPONENT. AS A RESULT, THE PATIENT UNDERWENT A LEFT KNEE REVISION APPROXIMATELY 4 YEARS AND 8 MONTHS AFTER INITIAL IMPLANTATION. NO FURTHER PATIENT IMPACT REPORTED. NO FURTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66477 TRULIANT PS CEM FEM PS CEM LEFT SZ 4 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862314451

    Patients

    Seq Age Sex Outcome Treatment
    1