BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FEMORAL COMPONENTS

    MDR report key: 14839149 · Received June 28, 2022

    Report

    Report Number
    1038671-2022-00728
    Event Type
    Injury
    Date Received
    June 28, 2022
    Date of Event
    May 31, 2022
    Report Date
    September 23, 2022
    Manufacturer
    EXACTECH, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, 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. (H3) AS REPORTED BY LEGAL BRIEF, PATIENT WAS INJURED AS THE RESULT OF A DEFECTIVE COMPONENT EXACTECH INC - OPTETRAK TOTAL KNEE REPLACEMENT SYS. THE EXACT NATURE AND EXTENT OF INJURIES ARE UNKNOWN CURRENTLY. NO ADDITIONAL INFORMATION AVAILABLE. 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 REPORTED EVENT BE CONCLUSIVELY DETERMINED; INSUFFICIENT INFORMATION. THESE DEVICES ARE USED FOR TREATMENT NOT DIAGNOSIS.

    Description of Event or Problem · 0

    AS REPORTED BY LEGAL BRIEF, PATIENT WAS INJURED AS THE RESULT OF A DEFECTIVE COMPONENT EXACTECH INC - OPTETRAK TOTAL KNEE REPLACEMENT SYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2017580 FEMORAL COMPONENTS PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED JWH EXACTECH, INC. FEMORAL COMPONENTS UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention