BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CR TIBIAL INSERT SZ 2, 11MM

    MDR report key: 18106961 · Received November 9, 2023

    Report

    Report Number
    1038671-2023-02735
    Event Type
    Injury
    Date Received
    November 9, 2023
    Date of Event
    August 4, 2021
    Report Date
    July 11, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862040206
    PMA / PMN Number
    K932776
    Removal / Correction Number
    Z-0019-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR AND OSTEOLYSIS. 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. ADDITIONALLY, A CONTRIBUTING FACTOR MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS. THE EXTENT AND ROOT CAUSE OF THE PROSTHESIS WEAR AND OSTEOLYSIS COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED, AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): 3924594 02-012-45-2020 - BANDEJA TIBIAL LOGIC FIT 2F/2T. 3932745 232-03-02 - COMP. FEMORAL ASIMETRICO POROSO CR Nº2 DCHA.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B5. G: REPORTING CONTACT - NAME AND EMAIL. H6: HEALTH EFFECT - CLINICAL CODE, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS.

    Description of Event or Problem · 0

    THIS 71 Y/O, FEMALE PATIENT UNDERWENT INITIAL TKA OF THE RIGHT KNEE ON (B)(6) 2015 AND WAS IMPLANTED WITH A CR INSERT TIBIAL SIZE 2, 11MM (CN: 200-22-11, SN: (B)(6). ON (B)(6) 2021 THE PATIENT¿S RIGHT KNEE WAS REVISED DUE TO UNKNOWN REASONS. DURING THE REVISION, CLEAR ASYMMETRY OF THE POLYETHYLENE CAUSED BY WEAR WAS NOTED. IT WAS DECIDED TO DO THE REVISION IN 2 STAGES. DURING THIS FIRST STAGE A CEMENT SPACER (ONLY) WAS PLACED. LATER ON (B)(6) 2021, THE PATIENT UNDERWENT THE SECOND STAGE OF THE REVISION. AT THIS TIME, IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT OSTEOLYSIS AND BONE LOSS IN THE TIBIA AND BOTH CONDYLES. THE SURGEON FELT THAT THIS WAS RELATED TO ASYMMETRICAL WEAR OF THE POLYETHYLENE INSERT. THE PATIENT WAS REVISED TO A JOHNSON & JOHNSON SIGMA TKA SYSTEM WITH ¿SLEEVES".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THIS PATIENT'S RIGHT TKA (TOTAL KNEE ARTHROPLASTY) WAS REVISED APPROXIMATELY 6 YEARS POST INITIAL OPERATION. THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS. DURING THE REVISION, CLEAR ASYMMETRY OF THE POLYETHYLENE CAUSED BY WEAR WAS NOTED. IT WAS DECIDED TO DO THE REVISION IN 2 STAGES. DURING THIS FIRST STAGE A CEMENT SPACER (ONLY) WAS PLACED. THEN 6 MONTHS LATER, THE PATIENT UNDERWENT THE SECOND STAGE OF THE REVISION. AT THIS TIME, IT WAS NOTED THAT THE PATIENT HAD SIGNIFICANT OSTEOLYSIS AND BONE LOSS IN THE TIBIA AND BOTH CONDYLES. THE PATIENT WAS REVISED TO A COMPETITORS DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1804906 CR TIBIAL INSERT SZ 2, 11MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862040206

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female SEE H10