BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM

    MDR report key: 15294108 · Received August 25, 2022

    Report

    Report Number
    1038671-2022-00968
    Event Type
    Injury
    Date Received
    August 25, 2022
    Date of Event
    July 29, 2022
    Report Date
    January 22, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862307699
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE RETURN STATUS NOT REPORTED. CONCOMITANTS MEDICAL DEVICE: 02-020-13-0335, 6172624 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5, 02-022-45-3535, 6483940 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T, 200-02-35, 6417544 - THREE PEG PATELLA 35MM, 201-78-15, 6486363 - HOLDING PIN MINI SHARP POINT 4 PK, 204-34-02, 6479665 - FLUTED STEM EXTENSION 25L X 14 MM, 204-70-00, 6385150 - TIBIAL STEM EXT. SCREW, 521-78-23, S036895 - THREADED PIN SIZE 2.3 COLLARED 2PK, 521-78-32, S047990 - THREADED PIN SIZE 3.0 COLLARLESS 2PK, 521-78-36, S041962 - THREADED PIN SIZE 5.1 COLLARLESS 2PK A10012, 02039120225 - GPS IMPLANT KIT V2. (B)(4). 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 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 H9: RECALL NUNBER.

    Additional Manufacturer Narrative · 0

    PENDING INVESTIGATION.

    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 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.

    Additional Manufacturer Narrative · 0

    "THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED WAS LIKELY THE RESULT OF INSTABILITY. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. HOWEVER, THE REPORTED PROSTHESIS WEAR COULD NOT BE CONFIRMED FROM THE PROVIDED INFORMATION AS THE IMAGE PROVIDED APPEARS UNREMARKABLE WITH RESPECT TO WEAR. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY."

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A FEMALE PATIENT, RIGHT KNEE INITIALLY IMPLANTED ON (B)(6) 2020, PRESENTED TO THE CLINIC WITH PAIN AND INSTABILITY AND WAS REVISED APPROXIMATELY 2 YEARS POST THE INITIAL PROCEDURE. THE SURGEON NOTED THE POLY WAS NOT WORN DOWN SIGNIFICANTLY. THERE WAS SOME MILD PITTING IN LATERAL AREA. FLEXION INSTABILITY WAS NOTED WITH MEDIAL GAPPING, BUT EXTENSION WAS GOOD. RELEASES WERE PERFORMED TO EVEN OUT GAPS AND THICKER INSERT WAS IMPLANTED. THE KNEE WAS WELL BALANCED WITH A 13MM CRC INSERT. FLEXION INSTABILITY WAS SIGNIFICANTLY RESOLVED. SURGEON WAS HAPPY WITH RESULT AND PATIENT LEFT IN STABLE CONDITION.

    Description of Event or Problem · 0

    NO PRODUCT RETURNING. EXPLANT IS NOT RELEASED TO THE REP PER HOSPITAL. THE REP DOES NOT HAVE ANY FURTHER INFORMATION.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION FROM LEGAL DEPARTMENT: REVISION OPERATIVE REPORT FOR RIGHT KNEE OF (B)(6) 2022: POSTOPERATIVE DIAGNOSIS: QUADRICEPS TENDON DISRUPTION, RIGHT KNEE. FLEXION INSTABILITY, MEDICAL COMPARTMENT, RIGHT KNEE. LATERAL COMPARTMENT POLYETHYLENE LINER WEAR. INTRAOPERATIVE FINDINGS: DURING THE PROCEDURE, RIGHT KNEE FLEXION INSTABILITY, MOST NOTABLY ON THE MEDIAL COMPARTMENT WAS APPRECIATED. THE QUADRICEPS TENDON TEAR WAS READILY APPRECIATED AND LATERAL COMPARTMENT POLYETHYLENE LINER WEAR WAS IDENTIFIED. AT THE COMPLETION OF PROCEDURE POSTERIOR CAPSULAR RELEASE WAS PERFORMED. A NEW POLYETHYLENE LINER WAS PLACED BALANCING THE KNEE WELL AND THE QUADRICEPS TENDON WAS REPAIRED. NO COMPLICATIONS. THE WOUND WAS CLOSED AND THE PATIENT WAS AWAKENED, WAS IN STABLE CONDITION AND WAS TRANSFERRED TO THE PACU. PATIENT IS TO FOLLOW UP WITH SURGEON IN THE CLINIC 2 WEEKS POST OPERATIVELY. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128474 TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, JWH EXACTECH, INC. TRULIANT TIB IMP CRC INSERT SZ 3.5, 9MM UNK 10885862307699

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Hospitalization| R SEE H10.