Smith & Nephew, a major British medical device manufacturer, has recalled the Journey knee replacement multiple times in the last few years. The problem is a defective femoral implant and/or tibial baseplate, which may fracture or fail prematurely. When this complication occurs, patients may develop extreme pain, instability, and need revision surgery.
Australian Health Officials Issue Journey BCS Recall
The Journey Bi-Cruciate Stabilized (BCS) knee replacement was recalled in Australia on January 6, 2014. Health officials with the Therapeutic Goods Administration (TGA) reviewed a national joint registry database and found unacceptable revision rates associated with the femoral implant / tibial baseplate combination:
- Revision surgery rate of 1.59 per 100 observed component years; compared to 0.72 rate for other total knee replacements.
- Yearly cumulative revision rate of 7% at five years, compared to 3.8% for other knee replacements.
- Reason for revision surgery was more likely to include patellofemoral pain, unspecified pain, and instability in the knee.
Class II Recall for Journey II Uni Tibial Baseplate
Approximately 40,000 Journey II Uni Tibial Baseplates have been recalled by the U.S. Food and Drug Administration (FDA) on March 3, 2010. The Class II recall was issued after Smith & Nephew began receiving complaints about defective baseplate breaking. This complication can cause severe pain, knee instability, and treatment involves revision surgery.
Journey Deuce Linked to High Failure Rate
The Smith & Nephew Journey Deuce knee replacement was associated with a 14% two-year failure-rate in a study published by the Journey of Arthroplasty in September 2011. One patient had a “catastrophically failed tibial baseplate.” Out of 36 cases, 31% of patients had poor results, and 53% said they would not repeat the surgery.
Symptoms of Knee Replacement Failure
- Knee pain or swelling
- Change in alignment of knee
- Loose or unstable knee
- Bone loss (osteolysis)
- Bone fracture
- Loss of knee flexibility or function
- Decreased walking ability
- Nerve damage
- Internal bleeding
- Blood clots
- Deep Vein Thrombosis (DVT)
- Pulmonary Embolism (PE)