BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS SLOPE++ SZ 4, 9MM

    MDR report key: 18743000 · Received February 20, 2024

    Report

    Report Number
    1038671-2024-00270
    Event Type
    Injury
    Date Received
    February 20, 2024
    Date of Event
    November 8, 2023
    Report Date
    August 5, 2024
    Manufacturer
    EXACTECH INC.
    Product Code
    JWH
    PMA / PMN Number
    K152170
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H11. ADDITIONAL MANUFACTURER NARRATIVE- ADDITIONAL INFORMATION ADDED. H3. INVESTIGATION RESULTS - THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF POLYETHYLENE WEAR. 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. HOWEVER, THE EXTENT AND ROOT CAUSE OF THE REPORTED POLYETHYLENE WEAR CANNOT BE DETERMINED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RADIOGRAPHS/PHOTOGRAPHS WERE NOT PROVIDED. THE SALES DATA FOR ALL TIBIAL INSERTS WAS USED TO CALCULATE A COMPLAINT OCCURRENCE RATE OF <0.5%, THIS IS CONSIDERED ¿VERY LOW¿. THIS SPECIFIC TIBIAL INSERT WAS PACKAGED FOR APPROXIMATELY 2 YEARS AND 7 MONTHS BEFORE BEING IMPLANTED. A REVIEW OF THE RISK DOCUMENTATION WAS CONDUCTED TO ENSURE THE RISK WAS INCLUDED AND THE OCCURRENCE IS BELOW THE THRESHOLD. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Additional Manufacturer Narrative · 0

    H10. D10. CONCOMITANTS: 6126177 02-020-13-0240 - TRULIANT CR CEM FEM CR CEM LEFT SZ 4 6219500 02-022-45-4040 - TRULIANT TIB FIT TRAY CEM SZ 4F / 4T 6003741 200-02-35 - THREE PEG PATELLA 35MM THESE DEVICES ARE USED FOR TREATMENTS, NOT DIAGNOSIS. PENDING INVESTIGATION. THERE IS NO OTHER INFORMATION AVAILABLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT A PATIENT HAD A LEFT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2020 AND THEN EXPERIENCED A REVISION SURGICAL PROCEDURE ON (B)(6) 2023 APPROXIMATELY 3 YEARS AND 10 MONTHS AFTER INITIAL IMPLANT. REVISION OP REPORT STATED LEFT KNEE WITH POLYETHYLENE FAILURE. NO IMAGES OF THE DEVICES ARE PROVIDED. THE DEVICE WILL NOT BE RETURNED. THERE IS NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    466035 TRULIANT TIB IMP CR INS SLOPE++ SZ 4, 9MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown Required Intervention SEE H10