BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 3980414 · Received August 5, 2014

    Report

    Report Number
    3010536692-2014-01079
    Event Type
    Injury
    Date Received
    August 5, 2014
    Report Date
    July 9, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. THIS EVENT OCCURRED IN THE (B)(6). THIS IS THE SAME EVENT AS 3010536692-2014-01078.

    Additional Manufacturer Narrative · 1

    COMPLAINT REVIEW WAS CONDUCTED AND ANALYSIS SHOWED NO TREND FOR ITEM/LOT.

    Description of Event or Problem · 1

    ALLEGEDLY PER ABSTRACT BY (B)(6) TO BE SUBMITTED TO THE 2014 (B)(6): FROM A CLINICAL STUDY OF 319 PATIENTS WITH ANCA-FIT STEMS: FOUR (4) HIPS DISLOCATED ONCE BUT DID NOT REQUIRE REVISION, TWO (2) HIPS WERE REVISED FOR RECURRENT DISLOCATION BETWEEN ONE AND ELEVEN YEARS FOLLOW UP. OF THESE 2 REVISIONS: ONE REQUIRED REVISION OF THE MODULAR NECK, HEAD, AND CUP; ONE OF THE TWO REQUIRED ONLY REVISION OF THE CUP. IN BOTH REVISIONS THE FEMORAL STEM WAS NOT REVISED. NO FURTHER INFORMATION ABOUT THE REVISIONS OR REVISED PARTS WAS GIVEN. NOTE: THIS DATA IS A FOLLOW UP OF THE 2009 ARTICLE "MID-TERM RESULTS OF THE MODULAR ANCA-FIT FEMORAL COMPONENT IN TOTAL HIP REPLACEMENT" ARTICLE PUBLISHED IN THE JOURNAL OF BONE & JOINT SURGERY BY BLAKEY ET AL. (RELATED COMPLAINT #S 10020114-129).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456647 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention