BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRAUMA IMPLANT

    MDR report key: 8461696 · Received March 28, 2019

    Report

    Report Number
    1020279-2019-01241
    Event Type
    Injury
    Date Received
    March 28, 2019
    Date of Event
    March 6, 2019
    Report Date
    June 8, 2019
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    MDM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BREAKAGE OF THE TIBIAL COMPONENT. IT WAS COMMUNICATED THAT THE EXPLANT WAS RECEIVED IN THE OFFICE IN GERMANY AND THEY DETERMINED THAT IT IS AN EFK KNEE. THE EFK KNEE IS MANUFACTURED BY ANOTHER COMPANY, NOT BY SMITH AND NEPHEW. FOR THIS REASON, THIS COMPLAINT HAS BEEN REQUESTED TO BE CLOSED. THE MANUFACTURER OF THE DEVICE HAS BEEN INFORMED OF THE ISSUE.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION ABOUT THIS EVENT WAS RECEIVED, IT WAS CONFIRMED THAT SMITH AND NEPHEW DID NOT MANUFACTURE THE EXPLANT INVOLVED IN THIS CASE. THE EXPLANTED DEVICE IS AN EFK KNEE MANUFACTURED BY THE THIRD PARTY MANUFACTURER (B)(4). THE MANUFACTURER OF THE DEVICE HAS BEEN INFORMED OF THE ISSUE. NO FURTHER INVESTIGATION WARRANTED FOR THIS COMPLAINT. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO BREAKAGE OF THE TIBIAL COMPONENT. NO MORE INFORMATION AVAILABLE. WAITING FOR THE WRITTEN INFORMATION FROM THE CLINIC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    252706 TRAUMA IMPLANT INSTRUMENT, MANUAL, SURGICAL, GENERAL USE MDM SMITH & NEPHEW, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R