BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HIP PROSTHESIS

    MDR report key: 5005222 · Received August 14, 2015

    Report

    Report Number
    1020279-2015-00577
    Event Type
    Malfunction
    Date Received
    August 14, 2015
    Date of Event
    July 22, 2015
    Report Date
    July 22, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    CUSTOMER INDICATED THAT THERE IS NO PRODUCT/DEVICE TO BE RETURNED FOR INVESTIGATION ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT 17 DAYS POST OP, THE FEMORAL NECK HAD COLLAPSED AND SHORTENED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    540446 HIP PROSTHESIS JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Other