BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ARCOM PATELLA

    MDR report key: 216158 · Received March 24, 1999

    Report

    Report Number
    1825034-1999-00040
    Event Type
    Injury
    Date Received
    March 24, 1999
    Date of Event
    January 18, 1999
    Report Date
    March 24, 1999
    Manufacturer
    BIOMET, INC.
    Product Code
    HTG
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    TOTOL KNEE ARTHROPLASTY WAS PERFORMED ON 11/25/1997. PATELLA COMPONENT WAS REMOVED ON 1/18/1999, DUE TO FRACTURE OF SPIKES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ARCOM PATELLA Implant PROSTHESIS, KNEE, COMP. HTG BIOMET, INC. NA 728510

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention