BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROFEMUR(R) HIP

    MDR report key: 2770116 · Received October 3, 2012

    Report

    Report Number
    1043534-2012-01263
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    February 1, 2012
    Report Date
    September 6, 2012
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    JDL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT NOT RETURNED. NO INFORMATION WAS PROVIDED REGARDING THE USER FACILITY OR THE EVENT.

    Additional Manufacturer Narrative · 1

    CONCLUSION: NO CONCLUSION CAN BE DRAWN.

    Description of Event or Problem · 1

    ALLEGEDLY PATIENT SUFFERED PAIN, LACK OF MOBILITY, LOOSENING AND METAL POISONING REQUIRING REVISION SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PROFEMUR(R) HIP HIP COMPONENT, CODE:JDL JDL WRIGHT MEDICAL TECHNOLOGY, INC. NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention