Smith & Nephew (S&N) has announced several recalls for the Journey knee replacement. The problem with some implants is a defective tibial baseplate or femoral implant. If these components break, patients may develop severe pain, instability, and require revision surgery.
Journey BCS Knee Recall in Australia
January 6, 2014 — The Journey Bi-Cruciate Stabilized (BCS) knee replacement system has been recalled by the Australian Therapeutic Goods Administration (TGA).
After reviewing a national database of joint implants, health officials recalled the femoral implant / tibial baseplate combination of the Journey BCS due to an unacceptably high rate of failure and revision surgery:
- Revision rate of 1.59 per 100 observed component years, compared to 0.72 for other total knee replacements.
- Yearly cumulative revision rate of 7% at five years post-implantation, compared to 3.8% for all other total knee replacements.
- Higher incidence of revision surgery for patellofemoral pain, unspecified pain, and instability.
Journey II Uni Tibial Baseplate Recall
March 3, 2010 — The U.S. Food and Drug Administration (FDA) has recalled Journey II Uni Tibial Baseplates. The Class II recall affects approximately 40,000 Journey II knee implants. Smith & Nephew has received complaints about baseplates breaking. When this occurs, patients must undergo revision surgery. If they do not, they could develop instability and premature wear of the implant.
Study Links Journey Deuce to High Failure Rate
September 2011 — The Journey of Arthroplasty has published a study of 36 people implanted with the Smith & Nephew Journey Deuce knee implant. They found that 14% of patients needed revision surgery within two years, including one patient who had a “catastrophically failed tibial baseplate.” In addition, 31% of patients reported poor results, and 53% said they would not have the surgery again.
Symptoms of Knee Replacement Failure
- Pain, swelling of knee or ankle
- Change in alignment of knee
- Loosening or instability
- Osteolysis (bone loss)
- Bone fractures
- Decreased knee function
- Stiffness in knee
- Damage to nerves or blood vessels
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)