BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PSC INSERT SZ 4, 10MM

    MDR report key: 15121694 · Received July 28, 2022

    Report

    Report Number
    1038671-2022-00854
    Event Type
    Injury
    Date Received
    July 28, 2022
    Date of Event
    July 11, 2022
    Report Date
    August 29, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862305275
    PMA / PMN Number
    K171045
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    PENDING EVALUATION.

    Additional Manufacturer Narrative · 0

    H3: THE REASON FOR THE PAIN AND SYNOVITIS LEADING TO THE REVISION REPORTED CANNOT BE DETERMINED FROM THE INFORMATION PROVIDED BUT DOES NOT APPEAR TO BE RELATED TO PROSTHESIS WEAR AS THE PROVIDED IMAGES APPEAR UNREMARKABLE. HOWEVER, THIS CANNOT BE CONFIRMED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION. A CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE IMPLANTED POLYETHYLENE COMPONENT IN THE PACKAGING RECALL. D10: 02-020-11-0340 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4 5972889. 02-022-45-4030 - TRULIANT TIB FIT TRAY CEM SZ 4F / 3T 6151122. 200-02-35 - THREE PEG PATELLA 35MM 6161992. 201-78-15 - HOLDING PIN MINI SHARP POINT 4 PK 5967752. CORRECTIONAL/REMOVAL NUMBER: Z-0023-2022.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 CLINICAL CODE, IMPACT CODE, PROBLEM CODE AND COMPONENT CODE.

    Description of Event or Problem · 0

    AS REPORTED, THIS PATIENT HAD A TKA ON (B)(6) 2019 PERFORMED BY DR. (B)(6). THE PATIENT PRESENTED WITH PAIN AND SYNOVITIS AND WAS REVISED ON (B)(6) 2022 AND A NEW INSERT WAS PLACED. ONLY MILD WEAR WAS NOTED. THE PATIENT HAD GOOD ROM AND WAS LAST KNOWN TO BE IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2333758 TRULIANT TIB IMP PSC INSERT SZ 4, 10MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. 02-022-44-4010 10885862305275

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H10.