BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 22384903 · Received July 2, 2025

    Report

    Report Number
    1038671-2025-02406
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    December 3, 2021
    Report Date
    September 3, 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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE UPDATED: H6 (TYPE OF INVESTIGATION). THE REASON FOR THE REPORTED REVISION DUE TO INFECTION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT MAY BE RELATED TO AN UNDERLYING PATIENT CONDITION AND/OR SURGICAL PROCEDURE. ADDITIONALLY, INFECTION IS A KNOWN SURGICAL RISK, AS OUTLINED IN THE IFU. 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

    D10: 02-020-12-0340 - TRULIANT PS POR FEM PS POR RIGHT SZ 4. 02-022-44-4011 - TRULIANT TIB IMP PSC INSERT SZ 4, 11MM. 02-022-55-4040 - TRULIANT POR TIB TRAY SIZE 4F/4T. 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT. 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 REVIEW OF MANUFACTURING DATA WAS UNABLE TO BE PERFORMED AS THE LOT INFORMATION OF THE PRODUCT INVOLVED IN THE EVENT WAS NOT AVAILABLE. 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.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. SUBSEQUENTLY, THE PATIENT EXPERIENCED PAIN AND WAS PRESCRIBED PHYSICAL THERAPY AND REFERRAL TO PAIN MANAGEMENT APPROXIMATELY 6 MONTHS AFTER INITIAL REPLACEMENT. THE PATIENT THEN EXPERIENCED INFLAMMATION AND SWELLING OF THE RIGHT KNEE. DURING THE FOLLOW-UP APPROXIMATELY 8 MONTHS AFTER INITIAL REPLACEMENT, THE PATIENT WAS NOTED TO HAVE A LOW-GRADE INFECTION AND WAS PRESCRIBED MEDICATION. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    170436 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Other SEE H11.