BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT

    MDR report key: 15642702 · Received October 20, 2022

    Report

    Report Number
    1038671-2022-01340
    Event Type
    Injury
    Date Received
    October 20, 2022
    Date of Event
    September 26, 2022
    Report Date
    April 3, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307637
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    NO DEVICE RETURN ANTICIPATED AS THEY ARE NOT RELEASED WITHOUT CONSENT. CONCOMITANTS MEDICAL DEVICES: 02-012-60-1425 - LOGIC STEM EXT 14MM X 25MM 6588058, 02-020-13-0330 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3 5861569, 02-022-45-3030 - TRULIANT TIB FIT TRAY CEM SZ 3F / 3T 6666423, 200-02-35 - THREE PEG PATELLA 35MM 6560355, 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 6684556, 201-78-98 - 2 PK, SCHANZ PIN, 4MM X 130MM 6737479, 204-70-00 - TIBIAL STEM EXT. SCREW 6580228, 521-78-23 - THREADED PIN SIZE 2.3 COLLARED 2PK S128891, 521-78-32 - THREADED PIN SIZE 3.0 COLLARLESS 2PK S092681, S092682, A10012 - GPS IMPLANT KIT V2 09019020060. ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6: BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY HAVE BEEN THE RESULT OF MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, OR ANY COMBINATION OF THESE POSSIBILITIES, WHICH LED TO PROSTHESIS WEAR.

    Additional Manufacturer Narrative · 0

    HAVING RECEIVED ADDITIONAL INFORMATION, THE FOLLOWING FIELDS HAVE BEEN UPDATED: A2, G3, H6. SUPPLEMENTAL INFORMATION AND/OR INVESTIGATION FINDINGS WILL BE REPORTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H6. INVESTIGATION CONCLUSION FOR PAIN: THE TRULIANT DEVICE WITH SERIAL NUMBER (B)(6) IS CONFIRMED TO HAVE BEEN PACKAGED IN A VACUUM BAG THAT DOES NOT CONTAIN EVOH. THE CAUSE OF THE PATIENT¿S PAIN AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. NO ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: H6: HEALTH EFFECT CLINICAL CODE, COMPONENT CODE, TYPE OF INVESTIGATION AND INVESTIGATION FINDINGS. SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H3, H6, H11. NO DEVICE WAS RETURNED FOR EVALUATION; PHOTOGRAPHS OF THE DEVICE WERE PROVIDED; HOWEVER, THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE REVISION REPORTED WAS LIKELY THE RESULT OF PAIN AND/OR DUE TO INCLUSION OF THE PATIENT¿S POLYETHYLENE COMPONENT IN THE PACKAGING RECALL. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, IMAGES OF THE OTHER COMPONENTS WERE NOT PROVIDED, AND ADDITIONAL PATIENT HISTORY WAS NOT PROVIDED. ADDITIONALLY, WEAR WAS NOTED ON THE TIBIAL INSERT IN THE PROVIDED IMAGE, WHICH MAY HAVE CONTRIBUTED TO THE REPORTED PAIN; HOWEVER, THE RELATIONSHIP BETWEEN THE INSERT WEAR AND THE PATIENT¿S PAIN CANNOT BE CONFIRMED SHOULD ADDITIONAL RELEVANT INFORMATION BE OBTAINED, A FOLLOW-UP MDR WILL BE SUBMITTED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2020, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2022, APPROXIMATELY 1 YEAR 9 MONTHS POST THE INITIAL PROCEDURE DUE TO PAIN. THE SURGEON PERFORMED RELEASES AND WENT UP TO AN 11MM INSERT WITH GOOD ROM AND STABILITY. HE NOTED MILD SYNOVITIS AND POLY WEAR. THE DAMAGE OF THE INSERT WAS FROM USING OSTEOTOME TO REMOVE IT. PATIENT LEFT IN STABLE CONDITION. THE DEVICE IS NOT RETURNING AS IT IS STANDARD PROCEDURE TO NOT RELEASE EXPLANTS WITHOUT PATIENT CONSENT. NO FURTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    REVISION OPERATIVE REPORT OF (B)(6) 2022. DIAGNOSES PAINFUL RIGHT KNEE ARTHROPLASTY WITH RIGHT POLYETHYLENE LINER EXCHANGE. INTRAOPERATIVE FINDINGS: SYNOVITIS WAS APPRECIATED, AND A PARTIAL SYNOVECTOMY WAS PERFORMED. POLYETHYLENE LINER WAS REMOVED. THERE WAS NO CATASTROPHIC WEAR ALONG THE POLYETHYLENE LINER. A MEDICAL SOFT TISSUE RELEASE AND A LARGER EXACTECH POLY LINER WAS IMPLANTED. THE PATELLA TRACKED WELL. FOLLOW UP WITH ORTHOPEDIC CLINIC 2 WEEKS POST OP FOR WOUND CHECK AND STAPLE REMOVAL. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    481719 TRULIANT PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3, 9MM UNK 10885862307637

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Required Intervention SEE H10.