BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT TIB IMP PS INSERT SZ 5 13MM

    MDR report key: 19477183 · Received June 6, 2024

    Report

    Report Number
    1038671-2024-01808
    Event Type
    Injury
    Date Received
    June 6, 2024
    Date of Event
    June 3, 2024
    Report Date
    June 6, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862304650
    PMA / PMN Number
    K152170
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: 4826265 02-022-45-5050 - TRULIANT TIB FIT TRAY CEM SZ 5F,5T. 4876527 02-020-11-0350 - TRULIANT PS CEM FEM PS CEM RIGHT SZ 5. 4924010 204-70-00 - TIBIAL STEM EXT. SCREW . 4933103 204-34-02 - FLUTED STEM EXTENSION 25L X 14 MM . 4947358 200-02-35 - THREE PEG PATELLA 35MM. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL [ENTER RECALL #]; HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 83 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT HAS EXPERIENCED PROSTHESIS WEARPAIN, STIFFNESS, DISCOMFORT, WEAKNESS, NEGATIVELY AFFECTED QUALITY OF LIFE, ADDITIONAL REVISION SURGERY, PHYSICAL ACTIVITIES LIMITED. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2331 TRULIANT TIB IMP PS INSERT SZ 5 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862304650

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention SEE H11