BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 22532913 · Received July 17, 2025

    Report

    Report Number
    1038671-2025-02512
    Event Type
    Injury
    Date Received
    July 17, 2025
    Date of Event
    January 31, 2024
    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: 02-020-14-0345 - TRULIANT CR POR FEM CR POR RIGHT SZ 4.5: (B)(6). 02-022-51-4513 - TRULIANT TIB IMP CRC INSERT SZ 4.5, 13MM: (B)(6). 02-022-55-4545 - TRULIANT POR TIB TRAY SIZE 4.5F/4.5T: (B)(6). 200-07-35 - ADVANCED PATELLA 35MM 3 PEG IMPLANT: (B)(6). THE DEVICE WILL NOT BE RETURNED FOR ANALYSIS; HOWEVER, AN INVESTIGATION OF THE REPORTED EVENT IS IN PROGRESS. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED. 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

    THE REASON FOR THE CLINICAL SYMPTOM OF PAIN REPORTED CANNOT BE CONCLUSIVELY DETERMINED AND THE EVENT CANNOT BE CONFIRMED BECAUSE THE DEVICES WERE NOT AVAILABLE FOR EVALUATION, AND RELEVANT PATIENT INFORMATION, IMAGES, OR RADIOGRAPHS WERE NOT PROVIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THE PATIENT UNDERWENT AN INITIAL TOTAL KNEE REPLACEMENT ON THE RIGHT SIDE. APPROXIMATELY FOUR YEARS AND THREE MONTHS POST-SURGERY, THE PATIENT DEVELOPED RIGHT KNEE PAIN THAT PERSISTED FOR TWO DAYS. THE PATIENT HAD TWO TEETH PULLED PRIOR TO KNEE PAIN ONSET. AS A RESULT, THE PATIENT CALLED THE OFFICE AND WAS PRESCRIBED ANTIBIOTICS. PATIENT REPORTED KNEE PAIN RESOLVED AFTER TAKING THE ANTIBIOTICS. IT IS UNKNOWN IF THE KNEE PAIN IS RELATED TO THE DENTAL WORK OR IF THERE WAS INFECTION PRESENT. THE OUTCOME OF THIS EVENT IS CONSIDERED RESOLVED. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    565423 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other SEE H11.