BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIOMET

    MDR report key: 1287069 · Received January 9, 2009

    Report

    Report Number
    MW5009582
    Event Type
    Malfunction
    Date Received
    January 9, 2009
    Date of Event
    December 17, 2008
    Report Date
    January 9, 2009
    Manufacturer
    BIOMET
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MN, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    EVENT DID NOT REACH PATIENT. DR WAS THE SURGEON. IT WAS REPORTED THAT DURING TOTAL KNEE ARTHROPLASTY IN LATE 2008, SURGEON WAS UNABLE TO ASSEMBLE THE LOCKING BAR TO THE TIBIAL TRAY COMPONENT. AN ALTERNATE LOCKING BAR COMPONENT WAS OPENED AND USED TO COMPLETE THE PROCEDURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BIOMET BIOMET INTERLOK FIXED I-BEAM TIBIAL PLATE 75MM HRS BIOMET 141224 391750

    Patients

    Seq Age Sex Outcome Treatment
    1 Other