BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP CR STD, SIZE 3.5, 10MM

    MDR report key: 18280381 · Received December 7, 2023

    Report

    Report Number
    1038671-2023-02932
    Event Type
    Injury
    Date Received
    December 7, 2023
    Date of Event
    June 19, 2023
    Report Date
    October 24, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    PMA / PMN Number
    K17104
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    AFTER REVIEW OF INFORMATION RECEIVED AND THE COMPLETION OF INVESTIGATION, THE FOLLOWING SECTIONS G1, G3, G6, H1, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. (H3): THE REASON FOR THE REVISION REPORTED CANNOT BE CONFIRMED FROM THE INFORMATION PROVIDED BUT MAY BE THE RESULT OF PROSTHESIS WEAR OR DUE TO INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND IMAGES AND RADIOGRAPHS WERE NOT PROVIDED.

    Additional Manufacturer Narrative · 0

    (H3) PENDING EVALUATION: (D10) CONCOMITANT DEVICE(S): (B)(6) 02-022-45-3535 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 3.5T. (B)(6) 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. (B)(6) 02-020-13-0335 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5.

    Description of Event or Problem · 0

    AS REPORTED BY THE EXACTECH (B)(6) CLINICAL STUDY, THE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2020. THE PATIENT PRESENTED ON (B)(6) 2023 WITH POLYETHYLENE WEAR WITHOUT EVIDENCE OF OSTEOLYSIS. POLYETHYLENE WEAR: MILD APPREHENSION WITH VARUS & VALGUS STRESS. THIS CASE IS RELATED TO (B)(4) (LEFT SIDE). THE CASE REPORT FORM INDICATES THAT THIS EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY NOT RELATED TO PROCEDURE. REVISION ON (B)(6) 2023. OUTCOME IS RESOLVED ON (B)(6) 2023. DUE TO CLINICAL STUDY, NO DEVICES WILL BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197324 TRULIANT TIB IMP CR STD, SIZE 3.5, 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Female SEE H10