BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 29MM

    MDR report key: 20951167 · Received December 17, 2024

    Report

    Report Number
    1038671-2024-04880
    Event Type
    Injury
    Date Received
    December 17, 2024
    Date of Event
    November 27, 2024
    Report Date
    March 19, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039583
    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

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. THE FOLLOWING SECTIONS WERE CORRECTED: B1, B2, D4, G2, G4, H6. THE REVISION REPORTED WAS LIKELY THE RESULT OF PROSTHESIS WEAR WHICH MAY HAVE BEEN DUE TO A COMBINATION UNEVEN PRESSURE DISTRIBUTION BETWEEN THE TIBIAL AND FEMORAL COMPONENTS AND PATIENT-RELATED CONDITIONS. THE REPORTED FRACTURE OF THE PATELLA PEGS CANNOT BE CONFIRMED AS THE DEVICE WAS NOT AVAILABLE FOR EVALUATION AND THE PROVIDED IMAGES DO NOT SHOW THE BACKSIDE OF THE DEVICE. 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 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. D10: 234-03-03 OPTETRAK ASY, PS CEMENTED FEMORAL, SZ 3, 1825605 204-04-33 TRAPEZOID TIBIAL TRAY SZ 3F/3T 1971059.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 13 YEARS AND 4 MONTHS POST THE INITIAL RIGHT TOTAL KNEE ARTHROPLASTY, THE PATIENT WAS REVISED DUE TO POLY ISSUES WITH FLAKING AND DELAMINATION OF THE PATELLA. THE THREE LUGS HAD SHEARED AWAY FROM THE PATELLA. THE LINER AND PATELLA WERE EXCHANGED. THERE WAS NO REPORTED BREAKAGE OF A DEVICE OR SURGICAL DELAY/PROLONGATION. THE PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    267219 THREE PEG PATELLA 29MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039583

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H