| Type of Product |
Medical Device |
| TGA Recall Reference |
RC-2014-RN-00004-1 |
| Product Name/Description |
Journey BCS Knee Replacement System - Femoral Implant
ARTG Number: 114462 |
| Recall Action Level |
Hospital |
| Recall Action Classification |
Class II |
| Recall Action Commencement Date |
3/01/2014 |
| Responsible Entity |
|
| Reason/Issue |
The Femoral Implant/Tibial Baseplate combination of the JOURNEY BCS Knee System has been identified in the Australian Orthopaedic Association’s National Joint Replacement Registry (AOANJRR) as having a higher than expected revision rate when compared to all other primary total knee replacements.. The AOANJRR data indicates that Journey BCS has a higher incidence of revisions due to patellofemoral pain, unspecified pain and instability. The most recent JOURNEY BCS Knee System revision data published by the NJRR include:
- A revision rate of 1.59 (1.34, 1.88) revisions per 100 observed component years compared to 0.72 (0.70, 0.73) for other total knee replacements; and
- A yearly cumulative percent revision of 7.0% (5.8, 8.4) at 5 years compared to 3.8% (3.7, 3.8) for other total knee replacements.
Smith & Nephew is withdrawing the Femoral Implant component of the JOURNEY BCS Knee System from the market. |
| Recall Action |
Hazard Alert |
| Recall Action Instructions |
Smith and Nephew is recommending that surgeons contact their patients who have been implanted with the Femoral Implant component as part of a primary knee replacement surgery and inform them of the current alert. Surgeons are advised to maintain standard follow-up protocols and actions for the care of their patients. Smith and Nephew do not recommend pre-emptive removal. Revision should only be undertaken when there are symptoms related to implant failure. JOURNEY BCS will no longer be available as a primary knee replacement system. The UHMWPE inserts of the JOURNEY BCS Knee System continues to be available for revision use. For more information, please see http://www.tga.gov.au/safety/alerts-device-journey-bcs-knee-replacement-system-140106.htm . |
| Contact Information |
02 9857 3999 - Smith & Nephew |