BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REPIPHYSIS DISTAL FEMUR

    MDR report key: 1013939 · Received March 12, 2008

    Report

    Report Number
    1043534-2008-00028
    Event Type
    Injury
    Date Received
    March 12, 2008
    Date of Event
    February 12, 2008
    Report Date
    February 14, 2008
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KRO
    PMA / PMN Number
    K021489
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. THIS REPORT WILL BE AMENDED WHEN THE INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    ALLEGEDLY PRODUCT MADE TO DOCTOR APPROVED SPECIFICATIONS, AND SAME DIMENSION AS IMPLANT PREVIOUSLY IMPLANTED; HOWEVER, DOCTOR SAID HE COULD NOT IMPLANT BECAUSE IT WAS 'WAY TOO BIG'. PATIENT WAS CLOSED BACK UP AND A SMALLER CUSTOM IMPLANT WAS MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 REPIPHYSIS DISTAL FEMUR KRO WRIGHT MEDICAL TECHNOLOGY, INC. 532352

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R