BEUDAMED
    FDA Adverse Event Injury Summary report: N

    THREE PEG PATELLA 35MM

    MDR report key: 16059686 · Received December 28, 2022

    Report

    Report Number
    1038671-2022-01634
    Event Type
    Injury
    Date Received
    December 28, 2022
    Date of Event
    December 2, 2022
    Report Date
    February 10, 2026
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862039606
    PMA / PMN Number
    K932690
    Removal / Correction Number
    Z-0026-2022
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN ISSUES. THE CAUSE OF PAIN AND THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION AS ASSOCIATED WITH THE INTERACTION BETWEEN THE IMPLANTED DEVICE [THE FEMORAL AND TIBIAL COMPONENTS MUST BE PLACED IN APPROPRIATE POSITIONS TO MINIMIZE ISSUES WITH THE PATELLOFEMORAL JOINT] AND THE PATIENT DUE TO PATIENT ILLNESS, UNIQUE ANATOMY, OR OTHER CONDITION THAT IMPACTS THE PERFORMANCE OF THE DEVICE. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS. CONCOMITANT DEVICE(S): 6061923, 02-010-01-0250 - LGC FEMORAL PS CEM LEFT SZ 5; 5802889, 02-012-38-5009 - LGC TIBIA PS RBK INSRT SZ 5 9MM; 5879117, 02-012-43-5040 - LGC TIBIA RBKTRAY CEM SZ 5F/ 4T.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2 YEARS POST OP THE INITIAL LEFT TKA, THIS 77 Y/O MALE PATIENT WAS REVISED DUE TO ANTERIOR KNEE PAIN. WASHOUT AND PATELLA LATERAL FACET RESECTION, THE PATELLA WAS REVISED TO AN EXACTECH DEVICE. PATIENT WAS LAST KNOWN TO BE IN STABLE CONDITION. THERE WERE NO ISSUES WITH THE REVISION PROCEDURE. NO OTHER PATIENT INFORMATION/MEDICAL HISTORY REPORTED. DEVICE WILL NOT BE RETURNING, THE HOSPITAL HAS NOT RELEASED IT. NO ADDITIONAL INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2547928 THREE PEG PATELLA 35MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL JWH EXACTECH, INC. 200-02-35 UNK 10885862039606

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Required Intervention