BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ARCOM AP PATELLA

    MDR report key: 336609 · Received June 7, 2001

    Report

    Report Number
    1825034-2001-00049
    Event Type
    Injury
    Date Received
    June 7, 2001
    Date of Event
    May 15, 2001
    Report Date
    June 5, 2001
    Manufacturer
    BIOMET, INC.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    TOTAL KNEE ARTHROPLASTY PERFORMED 07/1995. REVISION PERFORMED ON 05/2001, WHICH REPLACED TIBIAL BEARING AND PATELLA COMPONENTS. POST OF PATELLA COMPONENT FOUND TO BE SHEARED OFF AND X-RAY WIRE WAS EMBEDDED IN ARTICULAR SURFACE OF BEARING COMPONENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    26268 BIOMET ARCOM AP PATELLA PROSTHESIS, KNEE, COMP. HTG BIOMET, INC. NA 602400

    Patients

    Seq Age Sex Outcome Treatment
    1