BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 5 11MM

    MDR report key: 16584618 · Received March 21, 2023

    Report

    Report Number
    1038671-2023-00469
    Event Type
    Injury
    Date Received
    March 21, 2023
    Date of Event
    February 27, 2023
    Report Date
    February 19, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304636
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: INVESTIGATION RESULTS - THE REVISION REPORTED WAS LIKELY THE RESULT OF POLYETHYLENE WEAR, FEMORAL LOOSENING, AND PAIN AS STATED IN THE OPERATIVE NOTES AND EXPERIENCE REPORT. HOWEVER, THE PHOTOGRAPHED TIBIAL INSERT DOES NOT APPEAR TO SHOW SIGNS OF WEAR THAT ARE INCONSISTENT WITH IMPLANTATION. THE ASEPTIC (NON-INFECTED) FEMORAL LOOSENING MAY HAVE BEEN THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND/OR PATIENT-RELATED CONDITIONS. A CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE IMPLANTED POLYETHYLENE COMPONENT IN THE PACKAGING RECALL.

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION. CONCOMITANT MEDICAL PRODUCTS: 6156349, 02-020-11-0250 - TRULIANT PS CEM FEM PS CEM LEFT SZ 5. 5823532, 02-022-35-5011 - TRULIANT TIB IMP PS INSERT SZ 5 11MM .6132300, 02-022-45-5040 - TRULIANT TIB FIT TRAY CEM SZ 5F / 4T. 5842277, 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. S038756, 521-78-36 - THREADED PIN SIZE 5.1 COLLARLESS 2PK.

    Additional Manufacturer Narrative · 0

    SECTION H10: H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF AN INSUFFICIENT BOND BETWEEN THE FEMORAL COMPONENT AND THE BONE, WHICH LED TO ASEPTIC (NON-INFECTED) FEMORAL LOOSENING AND PAIN. A CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE IMPLANTED POLYETHYLENE COMPONENT IN THE PACKAGING RECALL. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. SECTION H11: THE FOLLOWING SECTIONS HAVE CORRECTED INFORMATION: H6: COMPONENT CODE: 4755, PART/COMPONENT/SUB-ASSEMBLY TERM NOT APPLICABLE.

    Additional Manufacturer Narrative · 0

    THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 3.5 YEARS POST OP THE INITIAL LEFT TKA, THIS 60 Y/O MALE PATIENT WAS REVISED DUE TO PAIN. PATIENT HAD A LOOSE FEMUR AND RECALLED POLY. NO BREAKAGE OF DEVICE OR SURGICAL DELAY. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. X-RAY & PHOTO ARE ATTACHED. PRODUCT IS NOT RETURNING, DUE TO RECALL HOSPITAL WILL NOT RELEASE IMPLANTS.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION VIA LEGAL DEPARTMENT: REVISION OPERATIVE REPORT OF 27 FEB 2023. POSTOPERATIVE DIAGNOSES: 1. FAILED LEFT TOTAL KNEE ARTHROPLASTY SECONDARY TO POLYETHYLENE WEAR. 2. ASEPTIC FEMORAL LOOSENING. 3. MEDIAL COMPARTMENT ARTHRITIS, RIGHT KNEE. INDICATIONS FOR PROCEDURE: THE PATIENT IS A 60-YEAR-OLD MALE WHO IS STATUS POST A PRIMARY LEFT TOTAL KNEE ARTHROPLASTY FOR OSTEOARTHRITIS. HE HAS HAD INCREASING EFFUSIONS OVER THE LAST COUPLE OF YEARS WITH A NEGATIVE INFECTION WORKUP. IN ADDITION, HE HAS HAD INCREASING RIGHT KNEE PAIN WITH X-RAY EVIDENCE OF BONE-ON-BONE MEDIAL COMPARTMENT ARTHRITIS. HE COMPLETED TWO INJECTIONS INTO THE KNEE WITH VISCOSUPPLEMENTATION. PROCEDURE: THERE WAS HEMOSIDERIN STAINING IN THE SYNOVIUM WHICH WAS DEBRIDED. THE PATELLA WAS SUBLUXED AND FOUND TO BE WELL FIXED. THE PATELLA WAS THEN EVERTED AND THE PREVIOUS POLYETHYLENE INSERT WAS REMOVED. THERE WAS EVIDENCE OF POLYETHYLENE WEAR. AT THIS POINT, THE COMPONENTS WERE CHECKED. THE FEMORAL COMPONENT WAS EASILY DISIMPACTED FROM THE INTACT CEMENT MANTLE ON THE FEMORAL SIDE. TIBIAL COMPONENT WAS WELL FIXED. THE PATIENT WAS AWAKENED AND TAKEN TO RECOVERY ROOM IN STABLE CONDITION. THERE WERE NO COMPLICATIONS. THE PATIENT WAS REVISED TO EXACTECH DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8231 TRULIANT TIB IMP PS INSERT SZ 5 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK UNK 10885862304636

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Male Required Intervention