BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADVANCE(R) PRESSFIT KEEL

    MDR report key: 3011612 · Received March 19, 2013

    Report

    Report Number
    1043534-2013-00553
    Event Type
    Injury
    Date Received
    March 19, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 12, 2013
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    MBH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN. THE COMPLAINT WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT. THE PACKAGE INSERT WAS ALSO REVIEWED AND PHOTOGRAPHIC IMAGES WERE MADE OF THE PRODUCT. EVIDENCE THAT PRODUCT IN SPECIFICATION WHEN USED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS IS THE SAME EVENT AS 1043534-2013-00550, 00551, 00552.

    Description of Event or Problem · 1

    ALLEGEDLY REVISION OF LEFT KNEE DUE TO PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    113092 ADVANCE(R) PRESSFIT KEEL KNEE INSTRUMENT, CODE:MBH MBH WRIGHT MEDICAL TECHNOLOGY, INC. 067425456

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention