BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET ORTHOPEDICS, INC.

    MDR report key: 2396531 · Received January 7, 2008

    Report

    Report Number
    2396531
    Event Type
    Injury
    Date Received
    January 7, 2008
    Date of Event
    April 4, 2004
    Report Date
    November 21, 2007
    Manufacturer
    BIOMET ORTHOPEDICS, INC.
    Product Code
    JWH
    Report Source
    User Facility report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PT UNDERWENT TOTAL KNEE ARTHROPLASTY ON (B)(6) 2004. RADIOGRAPHS ON (B)(6) 2005, INDICATED LOCKING BAR COMPONENT WAS DISENGAGED. REVISION SURGERY TO REPLACE COMPONENTS WAS PERFORMED ON (B)(6) 2005. THE DOCTOR THAT PERFORMED THE ORIGINAL SURGERY AND PLACED THE DEVICE DOES NOT WORK FOR THIS FACILITY AND SURGERY DID NOT TAKE PLACE IN THIS FACILITY. THE SURGERY ON (B)(6) 2005, TO REPAIR THE PROBLEM WAS PERFORMED BY ANOTHER PHYSICIAN AT THIS FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET ORTHOPEDICS, INC. BIOMET CC CRUCIATE TIBIAL TRAY 75MM JWH BIOMET ORTHOPEDICS, INC. 141234 789410

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention