BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK

    MDR report key: 211304 · Received February 23, 1999

    Report

    Report Number
    2219689-1999-00035
    Event Type
    Injury
    Date Received
    February 23, 1999
    Date of Event
    May 6, 1994
    Report Date
    February 22, 1999
    Manufacturer
    HOWMEDICA INC.
    Product Code
    JWH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    REPORTER STATED, "ON NOVEMBER 20, 1990, THE PLAINTIFF UNDERWENT SURGERY FOR A REPLACEMENT OF HIS LEFT HIP. ON MAY 6, 1994, IT WAS REPORTED THAT THE SYSTEM HAD FAILED AND THE PLAINTIFF UNDERWENT A SECOND SURGERY TO REMOVE A PORTION OF THE IMPLANTED SYSTEM THAT ALLEGEDLY HAD FAILED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNK Implant IMPLANT JWH HOWMEDICA INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention