| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2018-RN-00859-1 |
| Product Name/Description |
Journey BCS Knee System - Femoral Components
Journey BCS CoCr Femoral Component
Journey BCS Oxinium Femoral Component
Journey BCS Tibial Insert
All Batch/Lot Numbers
Multiple Catalogue Numbers
ARTG Number: 278110
(Smith & Nephew Pty Ltd - JOURNEY BCS Articular Insert - Prosthesis, internal, joint, knee, tibial component) |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
2/07/2018 |
| Responsible Entity |
|
| Reason/Issue |
In January 2014, Smith & Nephew issued a Hazard Alert for the Journey BCS Knee System (TGA Ref: RC-2014-RN-00004-1) which informed surgeons of the higher than expected revision rate identified by the AOANJRR and advised of the withdrawal of the Journey BCS Femoral component for primary surgery from the Australian market.
Smith & Nephew is now issuing an update following an analysis of the National Joint Registry of England, Wales & Northern Ireland (NJREWNI) & Australian Orthopaedic Association National Joint Replacement Registry (AOANJRR) data on the 1st generation Journey BCS Knee System.
The Journey BCS tibial insert remains available for use but should only be used for polyethylene exchange revision of first generation Journey BCS total knee constructs where the femoral component and tibial baseplate are well fixed. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Surgeons should maintain their routine follow-up protocol for patients who have undergone total knee arthroplasty. Signs and symptoms to consider for potential revisions are no different from those that might be reported by any patient having undergone primary total knee arthroplasty. The need for revision should be determined on a case-by-case basis following a detailed assessment of each patient’s clinical circumstances. Smith & Nephew is not recommending pro-active revision surgeries for patients implanted with this device.
This action has been closed out on 20/02/2019 |
| Contact Information |
02 9857 3918 - Smith & Nephew |