BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMK HYI AMER STD INSERTS

    MDR report key: 316546 · Received February 21, 2001

    Report

    Report Number
    1818910-2001-00067
    Event Type
    Injury
    Date Received
    February 21, 2001
    Date of Event
    August 18, 1998
    Report Date
    February 21, 2001
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    THE PT WAS REVISED BECAUSE THE POLY INSERT HAD DISINTEGRATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    6820 AMK HYI AMER STD INSERTS TOTAL KNEE PROSTHESIS JWH DEPUY ORTHOPAEDICS, INC. NA 806750023

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention