BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRULIANT KNEE COMPONENTS

    MDR report key: 25229233 · Received May 20, 2026

    Report

    Report Number
    1038671-2026-00628
    Event Type
    Injury
    Date Received
    May 20, 2026
    Date of Event
    April 16, 2018
    Report Date
    May 20, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OK, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 5173997, CATEGORY #: 02-020-13-0245 - TRULIANT CR CEM FEM CR CEM LEFT SZ 4.5, 4724743, CATEGORY #: 200-07-35 - ADVANCED PATELLA 35 MM 3 PEG IMPLANT, 5061516, CATEGORY #: 02-022-45-4545 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/4.5T, CATEGORY #: 02-022-51-4511 - TRULIANT TIB IMP CRC INSERT SZ 4.5, 11 MM. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES; NO DEVICE INFORMATION WAS PROVIDED. THE CAUSE OF THE PATIENT¿S INFECTION AND SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. 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 A PATIENT HAD AN INITIAL LEFT TOTAL KNEE ARTHROPLASTY. SUBSEQUENTLY, ONE (1) MONTHS LATER, THE PATIENT REPORTED EXPERIENCING MILD DRAINAGE, MILD SWELLING AND PAIN PERSISTS. TWO (2) MONTHS POST INITIAL IMPLANTATION, THE PATIENT PRESENTED WITH PERSISTING DRAINAGE SWELLING AND PAIN. THE PATIENT TREATMENT PLAN WAS DEBRIDEMENT OF LEFT KNEE, CULTURE AND SENSITIVITY SAMPLES AND ANTIBIOTICS DUE TO INFECTION. THE PATIENT¿S OUTCOME WAS LAST KNOWN AS CONTINUING. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37623 TRULIANT KNEE COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1