BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REPIPHYSIS® DISTAL FEMUR

    MDR report key: 5079396 · Received September 15, 2015

    Report

    Report Number
    3010536692-2015-01712
    Event Type
    Malfunction
    Date Received
    September 15, 2015
    Report Date
    September 11, 2015
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    KRO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WILL BE UPDATED WHEN INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT DATABASE WAS REVIEWED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    BROKEN SPRING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    609615 REPIPHYSIS® DISTAL FEMUR HIP COMPONENT KRO MICROPORT ORTHOPEDICS INC. 1452194

    Patients

    Seq Age Sex Outcome Treatment
    1 Other