BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 3 11MM

    MDR report key: 16782171 · Received April 20, 2023

    Report

    Report Number
    1038671-2023-00780
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    September 23, 2022
    Report Date
    September 13, 2023
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304278
    PMA / PMN Number
    K152170
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION H3: THE REVISION REPORTED IN THE CASE MAY HAVE BEEN THE RESULT OF POLYETHYLENE WEAR AND INSTABILITY AS STATED IN THE OPERATIVE NOTES. THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND PRE-REVISION RADIOGRAPHS AND IMAGES OF THE EXPLANTED DEVICES WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION. CONCOMITANT MEDICAL PRODUCTS:¿ 5889658 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM, 5963237 02-020-11-0330 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 3, 5968554 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T, 6038542 200-02-35 - THREE PEG PATELLA 35MM, 6019622 204-70-00 - TIBIAL STEM EXT. SCREW, 4026019012 A10012 - GPS IMPLANT KIT V2. CORRECTION REMOVAL NUMBER:Z-0023-2022.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION: A2, B5, B7, D8, & H6. MEDICAL DEVICE PROBLEM CODE. PENDING INVESTIGATION F6, F8- NA, THIS IS A MANUFACTURER'S REPORT.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL NOTIFICATION, THE FEMALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2019. THE PATIENT WAS REVISED ON (B)(6) 2022; REASON NOT REPORTED. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION: REVISION OPERATIVE REPORT OF OF (B)(6) 2023: INDICATIONS: PATIENT COMPLAINTS, EXAM AND IMAGING WORKUP WITH X-RAYS WERE SUGGESTIVE OF POSSIBLE POLYETHYLENE INSERT WEAR AND GLOBAL INSTABILITY OF THE KNEE. INDWELLING COMPONENTS OTHERWISE APPEARED TO BE APPROPRIATELY POSITIONED AND WELL-FIXED ON IMAGING. THE PATIENT'S INCREASED BODY HABITUS ADDED INCREASED TIME, EFFORT, AND REQUIRED SURGICAL EXPERTISE FOR THE PROCEDURE. FINDINGS: ON EXAM UNDER ANESTHESIA, THE PATIENT'S RIGHT KNEE DEMONSTRATED A WELL-HEALED TOTAL KNEE SCAR. THERE WAS NO ERYTHEMA, WARMTH, DRAINAGE, OR EXCESSIVE SWELLING NOTED ABOUT THE KNEE. KNEE RANGE OF MOTION DEMONSTRATED SLIGHT HYPEREXTENSION AND FLEXION TO 125 DEGREES. MIDLINE PATELLAR TRACKING IS NOTED THROUGH THAT ARC OF MOTION. THE KNEE EXHIBITED MILD LAXITY TO BOTH VARUS AND VALGUS STRESS IN FULL EXTENSION, AS WELL AS MID FLEXION. THE KNEE WAS STABLE TO ANTERIOR AND POSTERIOR DRAWER MANEUVERS IN FLEXION. SURGICAL EXPLORATION OF THE KNEE DEMONSTRATED A SMALL EFFUSION WITH NORMAL YELLOW JOINT FLUID. THERE WAS NO MACROSCOPIC EVIDENCE OF INFECTION THROUGHOUT THE KNEE. SYNOVIUM WAS LARGELY UNREMARKABLE IN APPEARANCE WITH SLIGHT SYNOVIAL HYPERTROPHY. THERE WAS NO EVIDENCE OF PARTICLE DISEASE ON INSPECTION OF THE SYNOVIUM. THE INDWELLING POLYETHYLENE INSERT EXHIBITED MINIMAL WEAR. THE CEMENTED FEMORAL AND TIBIAL COMPONENTS WERE FOUND TO BE APPROPRIATELY POSITIONED AND WELL-FIXED TO BONE ON VIGOROUS TESTING. THE PATELLAR BUTTON WAS ALSO UNREMARKABLE IN APPEARANCE AND WELL-FIXED TO BONE. SMALL BONY PERIPHERAL OSTEOPHYTES HAD DEVELOPED AROUND THE PATELLAR BUTTON, WHICH WERE REMOVED. WITH UPSIZING OF THE INSERT TO A 13 PS POLYETHYLENE INSERT, APPROPRIATE KNEE STABILITY WAS RESTORED WITH MINIMAL LAXITY TO VARUS AND VALGUS STRESS IN BOTH FLEXION AND FULL EXTENSION. THE TOURNIQUET WAS NOT UTILIZED DURING THE PROCEDURE. A DRESSING WAS APPLIED, THE PATIENT WAS SUBSEQUENTLY AWAKENED AND TRANSFERRED TO THE PACU IN STABLE CONDITION. PATIENT WILL RECEIVE 24 HOURS OF IV ANTIBIOTICS AND WILL BE DISCHARGED ON A WEEK'S WORTH OF ORAL ANTIBIOTICS TO COVER HER WHILE CULTURES ARE PENDING AND DUE TO INCREASED RISK OF PERIPROSTHETIC JOINT INFECTION GIVEN RELATED TO OBESITY. 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1520482 TRULIANT TIB IMP PS INSERT SZ 3 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-022-35-3011 10885862304278

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Female Required Intervention SEE H10