BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 4, 9MM

    MDR report key: 18117471 · Received November 12, 2023

    Report

    Report Number
    1038671-2023-02750
    Event Type
    Injury
    Date Received
    November 12, 2023
    Date of Event
    October 10, 2023
    Report Date
    June 26, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. CORRECTED FIELDS: B1, B2, D4, D6A, D10, G, G2, G3, H4, H6 D10: 3544700 02-010-03-0340 - LOGIC CR FEMORAL CEM, RIGHT, SZ 4 3752104 200-02-32 - THREE PEG PATELLA 32MM 3760434 02-012-45-4040 - LGC TIBIAL FIT TRAY CEM SZ 4F / 4T.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3. THE FOLLOWING SECTIONS WERE CORRECTED: D1, H6. H3: THE REVISION REPORTED WAS LIKELY THE RESULT OF THE REPORTED PAIN, INSTABILITY, AND WEAR OF THE POLYETHYLENE INSERT, OR DUE TO THE PACKAGING RECALL OF THE POLYETHYLENE. POSSIBLE CAUSES FOR POLYETHYLENE WEAR INCLUDE MALALIGNMENT BETWEEN THE IMPLANTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. INSTABILITY MAY BE THE RESULT OF INCREASED SOFT-TISSUE LAXITY (LOOSENESS), INADEQUATE FLEXION OF THE IMPLANTS, OR IMPROPER POSITIONING OR ALIGNMENT OF THE PROSTHESIS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 0

    AS REPORTED, THE PATIENT HAD UNDERGONE A PRIMARY RIGHT TOTAL KNEE ARTHROPLASTY WITH IMPLANTATION OF AN EXACTECH KNEE. OVER THE PAST TWO YEARS PATIENT HAS HAD INCREASINGLY WORSENING RIGHT KNEE PAIN AS WELL AS INSTABILITY AND SWELLING. PATIENT STATES THAT THE PAIN WAS BEGINNING TO NEGATIVELY IMPACT HIS DAY-TO-DAY LIVING, WITH THE WORSENING PAIN, PATIENT HAD A FOLLOW-UP WITH HIS SURGEON AND ON EXAM PATIENT HAD A SEVERE EFFUSION AND X-RAYS WERE SUGGESTIVE OF POLYETHYLENE WEAR. THE PATIENT WAS SCHEDULED FOR A REVISION OF RIGHT TOTAL KNEE ARTHROPLASTY AND POLYETHYLENE EXCHANGE. THE PATIENT WAS TAKEN BACK TO THE OR, INCISION WAS MADE THROUGH THE EXISTING INCISIONAL SCAR. WHEN THE ARTHROTOMY EXPOSURE WAS MADE, COPIOUS AMOUNTS OF JOINT FLUID IN EXCESS OF 100 ML CAME POURING OUT OF THE RIGHT KNEE JOINT. FLUID WAS NON PURULENT ALTHOUGH CULTURES WERE TAKEN. UPON FURTHER EXPOSURE OF THE RIGHT KNEE, THERE WAS EXTENSIVE AMOUNT OF SYNOVITIS IN ALL THREE COMPARTMENTS AS WELL AS PLASTIC DEBRIS. ONCE THE EXPOSURE ALLOWED FOR THE EXISTING POLYETHYLENE LINER TO BE REMOVED, RAPID OXIDATION COULD BE OBSERVED ON BOTH THE MEDIAL AND THE LATERAL COMPARTMENT RESULTING IN POLYETHYLENE WEAR. A MAJOR SYNOVITIS WAS PERFORMED. 6 L OF SALINE WITH A G OF CEFAZOLIN MIXED INTO IT WAS USED TO IRRIGATE THE RIGHT TOTAL KNEE ARTHROPLASTY. IN ADDITION TO THIS IRICEPT WAS USED. AFTER IRRIGATION, A NEW POLYETHYLENE LINER WAS INSERTED AND THE ARTHROTOMY AND SUPERFICIAL TISSUE WAS CLOSED. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. SALES REP WAS UNABLE TO OBTAIN IMAGES OR X-RAYS. THE DEVICE WILL BE RETURN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2219880 TRULIANT TIB IMP CRC INSERT SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. LINER UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| R