BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CC TIBIAL INSERT SZ 4, 13MM

    MDR report key: 13428194 · Received February 2, 2022

    Report

    Report Number
    1038671-2022-00148
    Event Type
    Injury
    Date Received
    February 2, 2022
    Date of Event
    May 11, 2020
    Report Date
    September 23, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    UDI-DI
    10885862054340
    PMA / PMN Number
    K954208
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION, INCLUDING THE PRODUCT INVESTIGATION, WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 0

    H7: Z-0019-2022. H6: 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 THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY 2.52 YEARS POST LEFT SIDE TKA, THIS MALE PATIENT UNDERWENT REVISION DUE TO PERSISTENT STIFFNESS. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. 510K: K954208.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258637 CC TIBIAL INSERT SZ 4, 13MM PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. CC TIBIAL INSERT SZ 4, 13MM UNK 10885862054340

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Required Intervention