BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HIP PROSTHESIS

    MDR report key: 4996231 · Received August 12, 2015

    Report

    Report Number
    1020279-2015-00562
    Event Type
    Injury
    Date Received
    August 12, 2015
    Date of Event
    July 26, 2015
    Report Date
    July 26, 2015
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THE PART WILL NOT BE RETURNED, THE INVESTIGATION TEAM WAS NOT ABLE TO CONDUCT ANY ANALYSIS ON THE PART. SINCE THE LOT NUMBER IS NOT LEGIBLE ON THE PART, A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE CONDUCTED TO CHECK FOR MANUFACTURING DEFECTS. IF PART RETURNS OR IF LOT NUMBER IS SENT BY THE CUSTOMER, THIS INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO IMPLANT FRACTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    528553 HIP PROSTHESIS JDH SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R