BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 4.5 13MM

    MDR report key: 19193894 · Received April 26, 2024

    Report

    Report Number
    1038671-2024-00994
    Event Type
    Injury
    Date Received
    April 26, 2024
    Date of Event
    April 8, 2024
    Report Date
    July 25, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304568
    PMA / PMN Number
    K171045
    Removal / Correction Number
    Z-0023-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (D10) CONCOMITANT DEVICE(S): 4777252 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT 4847415 02-022-45-4545 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/4.5T 4880932 02-020-11-0345 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 4.5.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED/CORRECTED: D4, H6 MDR SECTION CODES UPDATED/CORRECTED: B, C, D, E, G THE REASON FOR THE CLINICAL SYMPTOM OF PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE EVENT CANNOT BE CONFIRMED BECAUSE, THE DEVICES WERE NOT RETURNED FOR EVALUATION, BUT A RADIOGRAPH WAS PROVIDED. AN ADDITIONAL CONTRIBUTING FACTOR TO THE REVISION MAY HAVE BEEN INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL. 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

    AS REPORTED, THE 66 YEAR OLD MALE PATIENT HAD AN INITIAL RIGHT TKA ON (B)(6) 2017. THE PATIENT COMPLAINED OF PAIN AND UNDERWENT A POLY SWAP ON (B)(6) 2024. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE STABLE FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2127731 TRULIANT TIB IMP PS INSERT SZ 4.5 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862304568

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Male Required Intervention SEE H10