BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET ORTHOPEDIC IMPLANT

    MDR report key: 2219131 · Received August 17, 2011

    Report

    Report Number
    2219131
    Event Type
    Malfunction
    Date Received
    August 17, 2011
    Date of Event
    August 9, 2011
    Report Date
    August 15, 2011
    Manufacturer
    BIOMET
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    MO, US

    Narratives

    Description of Event or Problem · 1

    REVISED POLYMER INSERT WAS PLACED ON LEFT TOTAL KNEE REVISION. EXPLANTED POLYMER INSERT FAILED DUE TO BREAKAGE. IT WAS REPLACED WITH ANEW POLYMER INSERT PER DR. BARRACK. DEFECTIVE POLYMER INSERT INFORMATION: BIOMET CR STANDARD SIZE , 63/67 E POLY INSERT SN #(B) (6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDIC IMPLANT TOTAL KNEE POLY INSERT JWH BIOMET CR STANDARD E POLY 63 X 67 *

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR