BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 22495120 · Received July 14, 2025

    Report

    Report Number
    1038671-2025-02492
    Event Type
    Injury
    Date Received
    July 14, 2025
    Date of Event
    December 20, 2019
    Report Date
    July 23, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-020-12-0215 - TRULIANT PS POR FEM PS POR LEFT SZ 1.5: (B)(6). 02-022-35-1511 - TRULIANT TIB IMP PS INSERT SZ 1.5, 11MM: (B)(6). 02-022-55-1515 - TRULIANT POR TIB TRAY SIZE 1.5F/1.5T: (B)(6). 200-07-26 - ADVANCED PATELLA 26MM 3 PEG IMPLANT: (B)(6). THE REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. NO DEVICE WAS RETURNED FOR EVALUATION; FURTHER, PHOTOGRAPHS AND/OR RADIOGRAPH IMAGES WERE NOT PROVIDED FOR REVIEW. OPERATIVE NOTES AND/OR MEDICAL RECORDS WERE NOT PROVIDED FOR REVIEW OF USAGE/ TECHNIQUE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT EXACTECH PRODUCT DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT. AS A RESULT, THIS COMPLAINT EVENT IS NO LONGER CONSIDERED REPORTABLE BY EXACTECH AND THIS REPORT MAY BE DISREGARDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT BILATERAL TOTAL HIP REPLACEMENTS. SUBSEQUENTLY, THE PATIENT REPORTED EXPERIENCING BILATERAL KNEE PAIN APPROXIMATELY 8 MONTHS POST RIGHT KNEE PROCEDURE. RIGHT KNEE WAS MORE SEVERE, AND THUS TREATMENT PLAN WAS RTKA. PATIENT PRESENTED FOR LTKA. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1677587 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Female Required Intervention| H SEE H11