BEUDAMED
    FDA Adverse Event Other Summary report: N

    CONSENSUS KNEE SYSTEM

    MDR report key: 497477 · Received November 14, 2003

    Report

    Report Number
    2952369-2003-00003
    Event Type
    Other
    Date Received
    November 14, 2003
    Date of Event
    October 29, 2003
    Report Date
    November 14, 2003
    Manufacturer
    HAYES MEDICAL, INC.
    Product Code
    HSH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    THE SALES REPRESENTATIVE HAD GIVEN THE SURGEON AN IMPLANT THAT WAS PAST THE STERILIZATION EXPIRATION DATE. THE COMPONENT WAS IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CONSENSUS KNEE SYSTEM PCL SUBSTITUTING TIBIAL INSERT HSH HAYES MEDICAL, INC. NA 070252A

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other PATELLAR COMPONENT, TIBIAL VASEPLATE, FEMORAL| COMPONENT.