BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR INS STD SZ 4, 13MM

    MDR report key: 15546476 · Received October 5, 2022

    Report

    Report Number
    1038671-2022-01252
    Event Type
    Injury
    Date Received
    October 5, 2022
    Date of Event
    July 13, 2022
    Report Date
    May 7, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862306494
    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
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    CONCOMITANT DEVICE(S): 02-020-13-0240 - TRULIANT CR CEM FEM CR CEM LEFT SZ 4 6519329, 02-022-45-4050 - TRULIANT TIB FIT TRAY CEM SZ 4F / 5T 5954886, 200-02-35 - THREE PEG PATELLA 35 MM 6003772.

    Additional Manufacturer Narrative · 0

    SECTION H10: (H3) THE REPORTED REVISION 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. HOWEVER, THIS CANNOT BE CONFIRMED. ADDITIONALLY, A CONTRIBUTING FACTOR TO THE REPORTED POLYETHYLENE FAILURE MAY HAVE BEEN THE RESULT OF BEING PACKAGED IN A NON-CONFORMING VACUUM BAG FOR MORE THAN FIVE YEARS.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE REVISION REPORTED MAY HAVE BEEN THE RESULT OF PROSTHESIS WEAR AS STATED IN THE LEGAL DOCUMENTATION. POSSIBLE REASONS FOR THE TIBIAL INSERT WEAR INCLUDE MALALIGNMENT BETWEEN THE FEMORAL AND TIBIAL COMPONENTS, HIGH CONTACT STRESSES DURING KNEE FLEXION, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INSTABILITY, OR ANY COMBINATION OF THESE POSSIBILITIES. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND IMAGES OF THE EXPLANTED DEVICES AND PRE-REVISION RADIOGRAPHS WERE NOT PROVIDED. 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 THIS MALE PATIENT'S LEFT KNEE WAS REVISED APPROXIMATELY 2 YEARS POST OP DUE TO PREMATURE POLYETHYLENE WEAR OF THE TIBIAL INSERT. NO OTHER INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    531764 TRULIANT TIB IMP CR INS STD SZ 4, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 02-022-47-4013 UNK 10885862306494

    Patients

    Seq Age Sex Outcome Treatment
    1