BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECIFIC DEVICE NOT REPORTED

    MDR report key: 22384872 · Received July 2, 2025

    Report

    Report Number
    1038671-2025-02405
    Event Type
    Injury
    Date Received
    July 2, 2025
    Date of Event
    September 28, 2021
    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: 02-020-12-0340 - 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.

    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. D1: CORRECTED. H6: CORRECTED INVESTIGATION CLINICAL CODES.

    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. AS A RESULT, APPROXIMATELY 6 MONTHS AFTER INITIAL REPLACEMENT, THE PATIENT WAS PRESCRIBED PHYSICAL THERAPY AND REFERRAL TO PAIN MANAGEMENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO OTHER INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163847 SPECIFIC DEVICE NOT REPORTED PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC.

    Patients

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