BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 38MM

    MDR report key: 20929946 · Received December 13, 2024

    Report

    Report Number
    1038671-2024-04833
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    February 6, 2024
    Report Date
    December 13, 2024
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039613
    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

    H3: 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 PERFORMED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. A REVIEW OF COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO TRENDS WERE IDENTIFIED. THE INVESTIGATION RESULTS CONCLUDED THAT THE REPORTED EVENT OCCURRED DUE TO PROSTHESIS WEAR, INFECTION, AND AN INSUFFICIENT BOND BETWEEN THE PATELLA AND THE BONE. IT CANNOT BE CONFIRMED WHETHER THE PATELLA LOOSENED PRIOR TO INFECTION OR IF THE REPORTED INFECTION LED TO THE LOOSENING OF THE PATELLA. THE EXTENT AND ROOT CAUSE OF THE INFECTION, PROSTHESIS WEAR, AND PATELLA LOOSENING COULD NOT BE DETERMINED AS THE DEVICES WERE NOT RETURNED FOR EVALUATION, AND RADIOGRAPHS WERE NOT PROVIDED. IF ANY FURTHER INFORMATION IS OBTAINED THAT WOULD CHANGE OR ALTER ANY INFORMATION PROVIDED, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. H10: 4080159 - 244-03-04 - OPTETRAK ASY, HI-FLEX PS CEM FEM, SZ 4, RIGHT; 4282535 - 260-04-44 - RBK CEM FIN TIB TRAY SZ 4F/4T; 4375473 - 264-24-09 - RBK PS TIBIAL INSERT SZ 4, 09MM.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A 74 YO MALE PATIENT, INITIAL RIGHT KNEE IMPLANTED ON (B)(6) 2017, UNDERWENT A REVISION PROCEDURE ON (B)(6) 2024, APPROXIMATELY 6 YEARS 10 MONTHS POST THE INITIAL PROCEDURE. THE PATIENT WAS REVISED DUE TO POLY WEAR AND AN INFECTION. THE SURGEON TOOK THE ENTIRE CONSTRUCT DOWN DUE TO THE INFECTION. ALL COMPONENTS WERE REMOVED. THERE WERE NO DEVICE BREAKAGES OR SURGICAL DELAYS DURING THE PROCEDURE. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT. THE REP WAS UNABLE TO OBTAIN ANY X-RAYS. NO EXPLANTED DEVICES ARE AVAILABLE FOR ANALYSIS AS THEY WERE DISCARDED. DEVICE PHOTOS WERE PROVIDED. NO FURTHER INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936430 THREE PEG PATELLA 38MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039613

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Required Intervention SEE H10.