January 6, 2014 — The Smith & Nephew Journey Bi-Cruciate Stabilised (BCS) knee replacement has been recalled in Australia after it was linked to a doubled risk of revision surgery and failure compared to other knee implants. Patients with the Journey BCS who have unexpected pain or instability should contact their surgeon or hospital immediately.
In a safety alert, the Australian Therapeutic Goods Administration (TGA) warned that 7% of the implants fail within five-years, which is nearly double the 3.8% five-year failure rate associated with other knee implants.
Furthermore, investigators found a revision rate of 1.59 per 100 observed component years, which was more than double the revision rate of 0.72 for other knee replacements. The defective component is the femoral implant/tibial baseplate combination.
At this time, Smith & Nephew is not recommending revision surgery unless a patient is having problems with their Journey BCS knee replacement. The company has recommended that surgeons contact patients who received the implant, inform them of the issue, and maintain follow-up care.
Australian health authorities determined that there was a higher incidence of certain problems associated with the Journey BCS, including:
- Patellofermoal pain
- Unspecified pain
- Instability
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