BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 32MM

    MDR report key: 22998675 · Received September 8, 2025

    Report

    Report Number
    1038671-2025-02889
    Event Type
    Injury
    Date Received
    September 8, 2025
    Date of Event
    August 22, 2025
    Report Date
    September 8, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039590
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-022-51-3513 TRULIANT TIB IMP CRC INSERT SZ 3.5, 13MM: SN# (B)(6), 02-020-13-0335 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 3.5: SN# (B)(6), 02-022-45-3525 - TRULIANT TIB FIT TRAY CEM SZ 3.5F / 2.5T: SN# (B)(6). THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR OF THE TIBIAL INSERT AND INCLUSION OF THE POLYETHYLENE IMPLANTS IN THE PACKAGING RECALL. ADDITIONAL REASONS FOR THE REPORTED REVISION MAY BE PROSTHESIS WEAR OF THE PATELLAR COMPONENT, BUT THIS CANNOT BE CONFIRMED FROM THE PROVIDED INFORMATION. POSSIBLE CAUSES FOR POLYETHYLENE DAMAGE INCLUDE MALALIGNMENT BETWEEN IMPLANTS, THIRD BODY WEAR, PATIENT-RELATED CONDITIONS, INCLUSION OF THE POLYETHYLENE IN THE PACKAGING RECALL, OR ANY COMBINATION OF THESE POSSIBILITIES. POTENTIAL CONTRIBUTIONS OF USER AND PATIENT-RELATED CONSIDERATIONS TO THE EVENT COULD NOT BE ASSESSED AS THE DEVICES WERE NOT AVAILABLE FOR EVALUATION AND RELEVANT CLINICAL INFORMATION WERE 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 RADIOLUCENT OSTEOLYSIS AND PAIN. AS A RESULT, APPROXIMATELY FOUR YEARS POST-SURGERY, THE PATIENT UNDERWENT A REVISION. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER IMPACT TO THE PATIENT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS IS REPORT 1 OF 2 FOR THIS EVENT/PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2258372 THREE PEG PATELLA 32MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039590

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Female Hospitalization| R SEE H11