Smith & Nephew has recalled the Journey BCS knee replacement in Australia after health authorities linked it to a doubled risk of failure and revision surgery compared to other knee implants.
Journey Bi-Cruciate Stabilized (BCS) Knee Replacement
Smith & Nephew, one of the largest medical device manufacturers in the world, manufactures and sells the Journey BCS knee replacement worldwide. It has been on the market in the United States since 2007, and it is approved for men and women. It is a “bi-cruciate” knee implant, which means that it improves function of the anterior cruciate ligament (ACL) and posterior cruciate ligament (PCL).
Journey BCS Knee Recalled by Australian TGA
January 6, 2014 — The Australian Therapeutic Goods Administration (TGA) has recalled the Journey BCS knee replacement after linking it to an unacceptably high risk of failure and revision surgery. Health officials reviewed a national joint registry database and linked the Journey BCS to the following increased risks:
- Yearly cumulative revision rate of 7% at five years — double the risk of other knee implants, which have a 3.8% rate of failure.
- Revision rate of 1.59 per 100 observed component years — double the 0.72 rate of revision surgery from other knee implants.
What is the problem with the Journey BCS?
The problem with the Journey BCS knee may be a defective femoral component, according to the recall notification from Australian health officials:
“The femoral implant / tibial baseplate combination of the Journey BCS knee replacement system is having a higher than expected revision rate when compared to all other primary total knee replacements.”
Side Effects of Defective Knee Implants
The reasons for revision surgery with the Journey BCS knee were mostly typical of other knee replacements. However, there was a higher incidence of revision surgeries for instability, patellofemoral pain, and unspecified pain.
Defective knee implant risks & complications:
- Pain, inflammation, swelling
- Loose or unstable knee
- Tissue and nerve damage
- Bone fracture
- Bone loss (osteolysis)
- Revision surgery
- Decreased mobility
- And more
- Smith & Nephew Journey Knee Recall — Journey BCS, Journey II Uni Tibial Baseplate
- Journey BCS recall announcement – Australian Therapeutic Goods Administration (TGA)