BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FINN TIBIAL BEARING

    MDR report key: 86985 · Received April 25, 1997

    Report

    Report Number
    1825034-1997-00031
    Event Type
    Injury
    Date Received
    April 25, 1997
    Date of Event
    March 20, 1997
    Manufacturer
    BIOMET, INC.
    Product Code
    KRO
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PART NUMBER OF THE TIBIAL BEARING AND THE EXPLANT DATE WERE INCORRECT ON THE ORIGINAL MEDWATCH REPORT THAT WAS SENT ON 4/23/1997.

    Description of Event or Problem · 1

    TOTAL KNEE ARTHROPLASTY WAS PERFORMED ON 2/22/1995. REVISION SURGERY WAS PERFORMED ON 3/20/1997, DUE TO POLYETHYLENE WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FINN TIBIAL BEARING Implant PROSTHESIS, KNEE, COMPONENT KRO BIOMET, INC. NA 943590

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Hospitalization| R