BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) R DISTAL STEM

    MDR report key: 3971840 · Received July 31, 2014

    Report

    Report Number
    3010536692-2014-01058
    Event Type
    Injury
    Date Received
    July 31, 2014
    Report Date
    July 2, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THIS IS THE SAME EVENT AS 3010536692-2014-01057, -01059. THIS EVENT OCCURRED IN (B)(6).

    Description of Event or Problem · 1

    ALLEGEDLY PER PRESENTATION BY MANUAL RIBAS FOR DIDACTIC HIP TRAINING IN (B)(6) 2014, 1 HIP WAS REVISED FOR SUBSIDENCE. NO FURTHER DETAILS OF THE REVISION OR THE PATIENTS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446783 PROFEMUR(R) R DISTAL STEM HIP COMPONENT LZO MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention