BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) MODULAR FEMORAL NECK

    MDR report key: 3870619 · Received June 12, 2014

    Report

    Report Number
    3010536692-2014-00898
    Event Type
    Injury
    Date Received
    June 12, 2014
    Date of Event
    May 27, 2014
    Report Date
    May 28, 2014
    Manufacturer
    MICROPORT ORTHOPEDICS INC.
    Product Code
    LWJ
    Adverse Event
    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).

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    ALLEGEDLY A HIP REVISION OF DETAILED COMPONENTS DUE TO HIP PAIN. RADIOLUCENT LINES AROUND STEM. MILAN NECK EXTRACTOR TO REMOVE MODULAR NECK THEN TL STEM EXTRACTOR FOR STEM. RADIOLUCENT LINES SHOWED POSSIBLE LOOSENING BUT STEM WELL FIXED DISTALLY. CUP EXTRACTED BY EXPLANT. HIP IMPLANTED IN (B)(6) BY DR (B)(6). PRIMARY CASE NOT ON NJR. NJR REVISION NUMBER WILL BE GENERATED ON POST-SURGERY SUBMISSION OF SURGERY BY SURGEON/UNIT. EXPLANTED IMPLANTS RETAINED BY SURGEON. REVISION TO CPT STEM AND TRABECULAR METAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    348549 PROFEMUR(R) MODULAR FEMORAL NECK HIP COMPONENT LWJ MICROPORT ORTHOPEDICS INC. W02309808

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention