BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENTS

    MDR report key: 13367591 · Received January 27, 2022

    Report

    Report Number
    1038671-2022-00050
    Event Type
    Injury
    Date Received
    January 27, 2022
    Date of Event
    January 24, 2020
    Report Date
    September 2, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    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

    AFTER FURTHER REVIEW OF ADDITIONAL INFORMATION RECEIVED THE FOLLOWING SECTIONS G3, G6, H2, H3 AND H6 HAVE BEEN UPDATED ACCORDINGLY. AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT LTK IMPLANT, THIS FEMALE PATIENT WITH WITH BMI 28.5 UNDERWENT REVISION DUE TO INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION. BASED ON REVIEW OF ALL AVAILABLE INFORMATION, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT IS RELATED TO ANY DESIGN OR MANUFACTURING ISSUES. THE CAUSE OF THE SUBSEQUENT REVISION CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, IT IS MOST LIKELY RELATED TO THE PATIENT¿S UNDERLYING CONDITION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED, APPROXIMATELY SIX YEARS POST INITIAL RIGHT LTK IMPLANT, THIS FEMALE PATIENT UNDERWENT REVISION DUE TO INSTABILITY. NO ADDITIONAL INFORMATION IS AVAILABLE OR FORTHCOMING. THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84498 FEMORAL COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. FEMORAL COMPONENTS UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention