BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LPT GREAT TOE IMPLANT

    MDR report key: 4939093 · Received July 24, 2015

    Report

    Report Number
    1043534-2015-00045
    Event Type
    Injury
    Date Received
    July 24, 2015
    Date of Event
    January 7, 2015
    Report Date
    July 24, 2015
    Manufacturer
    WRIGHT MEDICAL TECHNOLOGY, INC.
    Product Code
    KWD
    PMA / PMN Number
    K864492
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION NOT COMPLETE. PRODUCT HAS NOT BEEN RETURNED. TRENDS WILL BE EVALUATED. THIS REPORT WILL BE UPDATED WHEN THE INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION COMPLETE, THE PRODUCT WAS SOLD BY WRIGHT MEDICAL WELL BEFORE THE EXPIRATION DATE. THE EXPIRATION OF THE IMPLANT WAS NOT NOTICED EITHER BY THE DISTRIBUTOR OR THE HOSPITAL BEFORE IMPLANTATION. THERE WERE NO COMPLAINTS RELATED TO INFECTION THAT WAS RECEIVED BY WRIGHT MEDICAL , AFTER IMPLANTATION OF THIS PARTICULAR EXPIRED PRODUCT.

    Description of Event or Problem · 1

    ALLEGEDLY, IMPLANT WAS IMPLANTED 3 MONTHS AFTER EXPIRY DATE. THE DATE OF THE ORIGINAL SURGERY (B)(6) 2015. A SALES REPRESENTATIVE WAS PRESENT DURING THE PROCEDURE. THERE SURGERY DID NOT EXTEND OVER 30 MINUTES. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON 7/1/2015 FROM MICHEL FLEURY: IN ISRAEL A HOSPITAL IMPLANTED A LPT IMPLANT THAT WAS EXPIRED ON MARCH 2015. IMPLANTATION SITE/PROCEDURE: HMIARTHOPLASTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    482676 LPT GREAT TOE IMPLANT SMALL JOINT COMPONENT KWD WRIGHT MEDICAL TECHNOLOGY, INC. 037406666

    Patients

    Seq Age Sex Outcome Treatment
    1 Other