BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WMT SLT TAPER COBALT-CHROME FEMORAL HEAD

    MDR report key: 2252197 · Received September 16, 2011

    Report

    Report Number
    1043534-2011-00553
    Event Type
    Malfunction
    Date Received
    September 16, 2011
    Date of Event
    June 1, 2011
    Report Date
    August 15, 2011
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    LZO
    PMA / PMN Number
    K932222
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS REVIEWED. THE ORIGINAL PACKAGING AND LABELING RETURNED AND INSPECTED. THE PRODUCT WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

    INVESTIGATION IS NOT COMPLETE. TRENDS WILL BE EVALUATED. THE EVENT CODE IS ADDRESSED IN THE PACKAGE INSERT. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE. ALTHOUGH SEVERAL ATTEMPTS HAVE BEEN MADE, NO MEDWATCH 3500 HAS BEEN RECEIVED FROM THE USER FACILITY.

    Description of Event or Problem · 1

    ALLEGEDLY PRODUCT HAD EXPIRATION DATE OF (B)(6) 2010 AND WAS SHIPPED TO HOSPITAL IN (B)(6) 2011. THIS FACILITY DID NOT HAVE A SALES REPRESENTATIVE PRESENT AT THE SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 WMT SLT TAPER COBALT-CHROME FEMORAL HEAD HIP COMPONENT LZO WRIGHT MEDICAL TECHNOLOGY, INC. 11233042

    Patients

    Seq Age Sex Outcome Treatment
    1