BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 41MM

    MDR report key: 23926214 · Received December 30, 2025

    Report

    Report Number
    1038671-2025-03649
    Event Type
    Injury
    Date Received
    December 30, 2025
    Date of Event
    September 12, 2022
    Report Date
    December 30, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039620
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: 02-012-51-4011 - LOGIC TIB INSERT IMPL CRC, SZ 4, 11MM, 02-010-04-0340 - LOGIC CR FEMORAL POR, RIGHT, SZ 4 (B)(6), 02-012-45-4050 - LGC TIBIAL FIT TRAY CEM SZ 4F / 5T (B)(6), G2: AUSTRALIA. H10: MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORT: 1038671-2022-01234. THE REVISION REPORTED IN THIS EVENT WAS MOST LIKELY THE RESULT OF PROSTHESIS WEAR INITIATED BY UNINTENDED CONTACT BETWEEN INCONGRUENT SURFACES OF THE TIBIAL INSERT AND FEMORAL COMPONENT. HOWEVER, CONTRIBUTIONS FROM INSTABILITY OF THE KNEE JOINT, COMPONENT ALIGNMENT, AND/OR PATIENT-CONDITIONS TO THE SEQUENCE OF EVENTS CANNOT BE DETERMINED FROM THE REPORTED CLINICAL INFORMATION. THE RETURNED PATELLA APPEARS TO HAVE LOCALIZED DAMAGE. THE REMAINDER OF THE ARTICULAR SURFACE APPEARS TO HAVE MINIMAL INDICATIONS OF DAMAGE. ONE OF THE PEGS APPEARS TO HAVE BEEN SHEARED OFF -MOST LIKELY DURING THE EXPLANTATION PROCESS. IF THE FEMORAL COMPONENT WAS IN FLEXION, THE APICAL DAMAGE PATTERN OF THE PATELLA MAY HAVE OCCURRED SECONDARY TO ARTICULAR CONTACT AGAINST THE FLATTER ANTERIOR PORTION OF THE FEMUR RATHER THAN ARTICULATING WITHIN THE TROCHLEAR GROOVE AS INTENDED. HOWEVER, THIS CANNOT BE CONFIRMED FROM THE PROVIDED INFORMATION. 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

    AS REPORTED, APPROXIMATELY 1.5 YEARS POST OP THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THIS PATIENT WAS REVISED DUE TO A SWOLLEN KNEE AND PAIN DUE TO POLYETHYLENE WEAR. THE INSERT AND PATELLA COMPONENTS WERE REVISED. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. NO FURTHER PATIENT IMPACT WAS REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1769898 THREE PEG PATELLA 41MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039620

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Hospitalization| R