BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT PS CEM FEM PS CEM LEFT SZ 3

    MDR report key: 18031060 · Received October 30, 2023

    Report

    Report Number
    1038671-2023-02629
    Event Type
    Injury
    Date Received
    October 30, 2023
    Date of Event
    May 12, 2023
    Report Date
    January 14, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862314437
    PMA / PMN Number
    K170240
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 5584703 02-012-60-1425 - TRU STEM EXT 14MM X 25MM. 5576627 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T. 5594848 200-02-32 - THREE PEG PATELLA 32MM. 5580052 204-70-00 - TIBIAL STEM EXT. SCREW. M001745 02-022-35-3011 - TRULIANT TIB IMP PS INSERT SZ 3 11MM. PENDING INVESTIGATION.

    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, PROSTHESIS WEAR, AND TIBIAL LOOSENING. THE REPORTED FEMORAL LOOSENING, PROSTHESIS WEAR, AND TIBIAL LOOSENING COULD NOT BE CONFIRMED. THE TIBIAL INSERT INVOLVED IN THIS CASE IS NOT WITHIN THE SCOPE OF THE POLYETHYLENE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED. D4: CORRECTED. H6: CORRECTED HEALTH EFFECT, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A LEFT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 6 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A LEFT KNEE REVISION ON (B)(6) 2023. THERE IS NO OTHER PATIENT DEMOGRAPHIC OR MEDICAL HISTORY AVAILABLE. THERE IS NO DEVICE RETURN. THERE ARE NO PHOTOS OR OTHER IMAGES OF THE DEVICE PROVIDED. NO ADDITIONAL INFORMATION IS AVAILABLE. REVISION OP REPORT ON (B)(6) 2023. DIAGNOSIS: FAILED LEFT TOTAL KNEE DUE TO PREMATURE POLY WEAR AND OSTEOLYSIS. THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS A GROSSLY LOOSE FEMORAL COMPONENT WITH NO ADHERENT BACK SIDE CEMENT. THERE WAS A SEVERE AMOUNT OF OSTEOLYSIS ON THE DISTAL FEMUR. THERE WAS A PARTIALLY LOOSE TIBIAL COMPONENT WITH A MODERATE AMOUNT OF PROXIMAL TIBIAL OSTEOLYSIS. THERE WAS A WELL-FIXED PATELLAR COMPONENT. THERE WAS A SEVERE AMOUNT OF EXTRANEOUS SYNOVIAL TISSUE AND COMPLETE SYNOVECTOMY WAS PERFORMED. THE PATIENT WAS AWAKENED AND TRANSFERRED TO RECOVERY IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2009516 TRULIANT PS CEM FEM PS CEM LEFT SZ 3 PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862314437

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Required Intervention SEE H10