BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 35MM

    MDR report key: 19927237 · Received August 7, 2024

    Report

    Report Number
    1038671-2024-02716
    Event Type
    Injury
    Date Received
    August 7, 2024
    Date of Event
    April 14, 2022
    Report Date
    February 4, 2025
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039606
    PMA / PMN Number
    K932690
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    D10 CONCOMITANT DEVICES: 4863424 200-02-35 - THREE PEG PATELLA 35MM. 5382369 02-020-13-0345 - TRULIANT CR CEM FEM CR CEM RIGHT SZ 4.5. 5770482 02-022-45-4545 - TRULIANT TIB FIT TRAY CEM SZ 4.5F/4.5T. THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL HOWEVER, THERE IS INSUFFICIENT INFORMATION TO EVALUATE WHETHER THE SUBJECT ISSUE OF THE RECALL WAS A CAUSE OR CONTRIBUTOR TO THE REPORTED EVENT. THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO MEDICAL OR OTHER RECORDS CONTAINING TREATMENT INFORMATION OR PATIENT INFORMATION HAVE BEEN RECEIVED; THEREFORE, THE REPORTED EVENT CANNOT BE CONFIRMED, NOR CAN THE CIRCUMSTANCES OR POTENTIAL CAUSES OR CONTRIBUTORS TO THE ALLEGED EVENT BE EVALUATED. SHOULD ADDITIONAL, MATERIAL INFORMATION BECOME AVAILABLE THAT PERMITS MORE ANALYSIS OR CONCLUSIONS, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY.

    Additional Manufacturer Narrative · 0

    1038671-2024-02717. CORRECTION: PLEASE DISREGARD THIS REPORT AS IT WAS REPORTED IN ERROR. EVENT WAS PREVIOUSLY REPORTED UNDER REPORT #1038671-2024-02717.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LEGAL DOCUMENTATION THAT APPROXIMATELY 36 MONTHS AFTER A RIGHT TOTAL KNEE REPLACEMENT PROCEDURE, THE PATIENT UNDERWENT A REVISION PROCEDURE TO ADDRESS PROSTHESIS WEAR. NO FURTHER ISSUES OR COMPLICATIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579779 THREE PEG PATELLA 35MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. UNK 10885862039606

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R SEE H11.