BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET MODULAR LOCKING BAR

    MDR report key: 1983622 · Received February 4, 2011

    Report

    Report Number
    MW5019312
    Event Type
    Injury
    Date Received
    February 4, 2011
    Date of Event
    December 22, 2010
    Report Date
    February 4, 2011
    Manufacturer
    BIOMET, INC.
    Product Code
    JWH
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    IA, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    BILATERAL KNEE REPLACEMENT ON (B)(6) 2010. APPROXIMATELY 5 WEEKS FROM SURGERY, SHE DEVELOPED PAIN, BURNING & BRUISING ON THE MEDIAL ASPECT OF HER KNEE. SHE RETURNED TO SURGERY FOR REMOVAL OF THE LOOSE LOCKING PIN OF THE TIBIAL TRAY AND INSERTION OF A NEW CLIP. RECOVERY HAS BEEN WITHOUT INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET MODULAR LOCKING BAR LOCKING PIN JWH BIOMET, INC. 890310

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Hospitalization