BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3.5 11MM

    MDR report key: 17557618 · Received August 16, 2023

    Report

    Report Number
    1038671-2023-01967
    Event Type
    Injury
    Date Received
    August 16, 2023
    Date of Event
    January 6, 2023
    Report Date
    May 9, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304360
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10: CONCOMITANTS: 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5 5040338 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T 4829017 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM 4208683 204-70-00 - TIBIAL STEM EXT. SCREW 4163167 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 PROSTHESIS WEAR, INSTABILITY, DISASSEMBLY AND FEMORAL LOOSENING OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF MANUFACTURING, USER, AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES, RADIOGRAPHS, AND PRODUCT INFORMATION WERE NOT PROVIDED. B5: CORRECTED. D10 CONCOMITANTS: 02-020-11-0335 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3.5 (B)(6). 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T (B)(6). 204-34-04 - FLUTED STEM EXTENSION 40L X 14 MM (B)(6). 204-70-00 - TIBIAL STEM EXT. SCREW (B)(6). H6: CORRECTED HEALTH EFFECT, MEDICAL DEVICE, COMPONENT, AND INVESTIGATION CLINICAL CODES.

    Description of Event or Problem · 0

    AS REPORTED VIA LEGAL DOCUMENTATION THE PATIENT HAD A RIGHT KNEE REPLACEMENT ON (B)(6) 2018. APPROXIMATELY 4 YEARS AND 10 MONTHS AFTER THE INITIAL PROCEDURE THE PATIENT HAD A RIGHT 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 POLYETHYLENE COMPONENT, RIGHT TOTAL KNEE DUE TO WEAR WITH LOOSE FEMORAL COMPONENT. FINDINGS: THERE WAS FOUND TO BE A CLEAN WOUND WITH CLEAR SYNOVIAL JOINT FLUID. THERE WAS EVIDENCE OF POLYETHYLENE WEAR WITH ENCAPSULATED POLYETHYLENE DEBRIS WITHIN THE SYNOVIUM AND A COMPLETE SYNOVECTOMY WAS PERFORMED. THERE WAS FOUND TO BE A LOOSE FEMORAL COMPONENT FROM THE CEMENT MANTLE AND THERE WAS AN UN-RESURFACED PATELLA DUE TO A THIN, NATIVE, WORN PATELLA FROM PREVIOUS SURGERY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT APPROXIMATELY 58 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR, SEVERE PAIN, SIGNIFICANT SCARRING, SWELLING, EFFUSION, INFLAMMATION, KNEE POPPING/CLUNKING, KNEE INSTABILITY, DIFFICULTY WALKING, ANTALGIC GAIT, ANXIETY, AND EMOTIONAL DISTRESS. REVISION SURGERY OPERATIVE NOTES WERE PROVIDED. THE SURGEON PERFORMED A REVISION OF THE RIGHT KNEE POLYETHYLENE AND FEMORAL COMPONENT. PATIENT LEFT THE OPERATING ROOM IN STABLE CONDITION. POST OPERATIVE DIAGNOSIS NOTED THAT THE TIBIAL POLYETHYLENE COMPONENT HAD DISENGAGED FROM THE TIBIAL TRAY COMPONENT. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    491321 TRULIANT TIB IMP PS INSERT SZ 3.5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, CEMENTED, POLYMER/METAL/POLYMER JWH EXACTECH, INC. UNK 10885862304360

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention SEE H10.