BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMK TIB INS SIZE 4 8MM

    MDR report key: 250862 · Received November 23, 1999

    Report

    Report Number
    1818910-1999-00223
    Event Type
    Injury
    Date Received
    November 23, 1999
    Date of Event
    October 27, 1999
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    COMPONENTS REMOVED DUE TO WEAR AND LOOSENING. DOI: 91; DOR: 99. THE PT HAS MODERATE; NORMAL ACTIVITY LEVEL AND HE IS RETIRED. PHONE CONVERSATION WITH USER FACILITY UP (11-04-99) FOUND THAT THE TIBIAL INSERT (1488-60-000) WAS WORN AND THE P/S LATERAL WAS BROKEN. THE PATELLA (1488-18-000) WAS WORN ALMOST TO METAL ON METAL. THE TIBIAL TRAY (1488-25-000) WAS LOOSE. THE COMPONENTS ARE NOT COMING BACK AS THEY HAVE BEEN FORWARDED TO THE DR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 AMK TIB INS SIZE 4 8MM Implant TOTAL KNEE PROSTHESIS JWH DEPUY ORTHOPAEDICS, INC. NA 614660085

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention