BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OFFSET TIB TRAY 2.5MM ADAPTOR

    MDR report key: 2840828 · Received November 20, 2012

    Report

    Report Number
    0001825034-2012-02431
    Event Type
    Malfunction
    Date Received
    November 20, 2012
    Date of Event
    August 30, 2012
    Report Date
    November 12, 2012
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    1825034-2012-018R
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION OF RETURNED DEVICE CONFIRMED REPORTED CONDITION. DECISION WAS MADE TO RECALL BASED ON AN OPERATOR ISSUE THAT WAS DETERMINED AS PART OF AN INTERNAL INVESTIGATION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PATIENT UNDERWENT REVISION KNEE ARTHROPLASTY PROCEDURE ON (B)(6) 2012 TO REMOVE SPACERS THAT WERE PLACED DUE TO INFECTION. DURING THE PROCEDURE, THE OFFSET TIBIAL TRAY ADAPTOR WOULD NOT ENGAGE. ANOTHER TIBIAL TRAY ADAPTOR WAS AVAILABLE TO COMPLETE THE PROCEDURE WITHOUT INJURY TO THE PATIENT. THERE WAS NO SIGNIFICANT DELAY AS A RESULT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OFFSET TIB TRAY 2.5MM ADAPTOR PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 378330

    Patients

    Seq Age Sex Outcome Treatment
    1