January 6, 2014 — Australia’s Therapeutic Goods Administration (TGA) will recall the Smith & Nephew Journey Bi-Cruciate Stabilised (BCS) knee replacement after linking it to a doubled increased risk of premature failure and revision surgery than other knee replacements.
The defective component is the femoral implant/tibial baseplate combination. Patients who have unexpected pain or instability are advised to contact their surgeon or hospital immediately.
According to the safety alert, approximately 7% of Journey BCS knee implants fail within five years, which is nearly twice as high as the 3.8% rate of failure from other knee replacements.
Australian investigators also found a revision rate of 1.59 per 100 observed component years, which is more than twice as high as the 0.72 revision rate associated with other knee implants.
At this time, the Journey BCS is only being recalled in Australia. Smith & Nephew does not advise routine revision surgery unless a patient is experiencing problems. They recommend that surgeons contact their patients to inform them about the problem.
The Journey BCS has been associated with a higher incidence of the following complaints in Australia:
- Patellofermoal pain
- Unspecified pain
- Instability
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