BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GII STANDARD TIBIA B

    MDR report key: 2904045 · Received January 9, 2013

    Report

    Report Number
    1020279-2013-00019
    Event Type
    Injury
    Date Received
    January 9, 2013
    Date of Event
    December 26, 2012
    Report Date
    December 26, 2012
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCTS WERE RETURNED. THE COMPLAINT NOTED A REVISION WAS PERFORMED DUE TO INFECTION. ACCORDING TO SMITH & NEPHEW STERILIZATION RELEASE DOCUMENTATION, THE PRODUCTS WERE VERIFIED FOR STERILIZATION PRIOR TO THE PRODUCTS SHIPPING. A REVIEW OF COMPLAINT HISTORY REVEALED THAT THIS IS THE FIRST COMPLAINT WE'VE RECEIVED FOR THE IDENTIFIABLE BATCHES. SAFETY AFFAIRS WILL CONTINUE TO MONITOR THIS DEVICE/ FAILURE MODE FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO INFECTION. WHILE THE SURGEON WAS PERFORMING THE REVISION, THE SURGEON HAD DIFFICULTIES REMOVING THE IMPLANTS WHICH EXTENDED THE SURGERY TIME FOR SEVERAL HOURS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A REVISION WAS PERFORMED DUE TO INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    11174 GII STANDARD TIBIA B GNS II CMT TIB SIZE 6 {} LEFT JWH SMITH & NEPHEW, INC. 02BM01219

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention OFFSET COUPLER AND TIBIAL STEM/UNKNOWN| (B)(4)| (B)(4)| FEMORAL/UNKNOWN| POLY PATELLA/UNKNOWN| (B)(4)| (B)(4)