BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OSS RS FEMORAL BUSHING

    MDR report key: 1051541 · Received May 16, 2008

    Report

    Report Number
    1825034-2008-00128
    Event Type
    Malfunction
    Date Received
    May 16, 2008
    Date of Event
    October 9, 2006
    Report Date
    February 2, 2007
    Manufacturer
    BIOMET, INC.
    Product Code
    KRO
    PMA / PMN Number
    K021260
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERE HAVE BEEN NO TRENDS IDENTIFIED RELATED TO THIS TYPE OF EVENT. OTHER - EVAL OF RETURNED DEVICES FOUND IMPLANTS TO BE OUT OF DESIGN SPECS. IN RESPONSE TO RECENT FDA AUDIT, RETROSPECTIVE REVIEW WAS PERFORMED, EVENT WAS REASSESSED AND DETERMINED TO MEET REPORTING REQUIREMENTS AS DEVICE MALFUNCTION. CORRECTIVE AND PREVENTIVE ACTIONS HAVE BEEN INITIATED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING KNEE PROCEDURE IN 2006, BUSHING SET DID NOT FIT IN THE FEMORAL COMPONENT. ADDITIONAL BUSHING SET WAS OPENED AND FIT FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 OSS RS FEMORAL BUSHING KRO BIOMET, INC. NA 231980

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK