BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 32MM

    MDR report key: 21576762 · Received March 11, 2025

    Report

    Report Number
    1038671-2025-01549
    Event Type
    Injury
    Date Received
    March 11, 2025
    Date of Event
    March 7, 2025
    Report Date
    March 11, 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
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    D10: (B)(6) 02-012-60-1425 - TRU STEM EXT 14MM X 25MM (B)(6) 02-020-11-0225 - TRULIANT PS CEM FEM PS CEM LEFT SZ 2.5 (B)(6) 02-022-45-2525 - TRULIANT TIB FIT TRAY CEM SZ 2.5F / 2.5T (B)(6) 204-70-00 - TIBIAL STEM EXT. SCREW (B)(6) 02-022-44-2509 TRULIANT TIB IMP PSC INSERT SZ 2.5, 9MM MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: THE PRODUCT ASSOCIATED WITH THE REPORTED EVENT IS WITHIN THE SCOPE OF RECALL 1038671-04/18/2024-002-R; 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 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.

    Description of Event or Problem · 0

    IT WAS REPORTED APPROXIMATELY 15 MONTHS AFTER THE PATIENT'S FIRST LEFT KNEE REVISION SURGERY, THE PATIENT UNDERWENT A SECOND LEFT KNEE REVISION. THE PATIENT WAS NOT SHOWING ANY SIGNS OF PAIN OR DISCOMFORT NOR ANY OSTEOLYSIS. PATIENT HAD AN INSERT AND PATELLA REVISED DUE TO RECALL. NO SURGICAL OR MEDICAL INTERVENTIONS WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    335708 THREE PEG PATELLA 32MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 10885862039590

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Female Required Intervention| H SEE H11