Medical device manufacturer Smith & Nephew has issued a Field Safety Corrective Action (FSCA) for its first-generation Journey knee implant due to unreasonably high failure rates from femoral component loosening, necessitating exceedingly painful and risky revision surgeries.
Total knee replacement, or total knee arthroplasty, is a common surgical procedure that involves part of the knee joint being replaced with artificial parts. Knee replacement is an option when patients don’t respond to less invasive treatments, such as medication, weight loss, or walking supports. Approximately 700,000 knee replacements are performed in the U.S. each year. Experts are protecting this number to increase to 3.48 million procedures annually by 2030.
As one of the leading manufacturers of joint replacement components, Smith & Nephew’s Journey bi-cruciate stabilized (BCS) knee has been used in a number of these procedures. When the device received FDA approval in August 2007, Smith & Nephew aggressively marketed the Journey knee implant as providing patients with massively increased range-of-motion and stability. However, since its approval, Journey BCS knee patients have reported significant complications with the implant, particularly the loosening of essential joint components that have necessitated risky and painful revision or reconstructive surgeries to repair.
On January 6, 2014, Australia’s Therapeutic Goods Administration (TGA) took regulatory action and issued a Journey BCS knee recall to protect the country’s patients after connecting the device to having more than double the risk for premature failure and revision surgery than other knee implants. The regulatory agency isolated the defective component as the femoral implant/tibial baseplate combination.
After reviewing a national joint implant database, health officials found that the Journey knee had:
In response to these same studies, Smith & Nephew simply phased out the first-generation Journey knee replacement rather than issue a proper recall. Consequently, surgeons have continued using the components they have in stock. However, as complaints over the defective knee have continued to flood the FDA’s adverse events database, the manufacturer is finally acting to protect patients more than four years after Australia issued its recall of the dangerous device.
Due to escalating complaints over painful and debilitating injuries from the device, Smith & Nephew is notifying all physicians on record as receiving first-generation Journey knee components and urging them to return any unused inventory as soon as possible to avoid further injuries.
In response to the FCSA notice, the Medicine & Healthcare products Regulatory Agency (MHRA) released a medical device alert of its own to physicians in England, Scotland, Northern Ireland, and Wales. The agency is asking physicians to locate and return Journey BCS components still in stock and to monitor patients with the devices for signs of loosening. The MHRA is also requesting for doctors to consider conducting annual reviews for the first 5 years post implantation, then every two to 10 years, and to report adverse events to their national incident reporting authority as soon as possible.
There are a number of painful and debilitating problems associated with knee implant failure. Notify your doctor if you experience any of the following:
Patients who experience premature knee implant failure face substantially higher risks when undergoing revision surgery. These procedures are generally far more painful and invasive than the original knee replacement. During revision or replacement surgery surgeons usually need to break the faulty device away from the bone where it is often cemented into place. Furthermore, these defective implants can damage surrounding bone to the extent that a reconstructive surgery is necessary to completely rebuild the knee before a replacement device can even be implanted.
On top of the extremely painful surgery and extensive rehabilitation period, revision and reconstructive surgeries can also expose patients to a higher risk of infection and other surgical complications. These include excessive bleeding, deep venous thrombosis, nerve or blood vessel damage, and pulmonary embolism.
McGartland Law is currently pursuing possible lawsuits for patients who have experienced painful and incapacitating injuries from Journey knee failure. If you, or a loved one, required knee revision or reconstructive surgery due to Journey knee component loosening, you may be eligible to participate in a financial recovery for your medical bills and lost wages, as well as your pain and suffering.
Knee implant failure is already hard enough to recover from. You don’t have to do it on your own. Let McGartland Law’s experienced team help you explore your legal rights, responsibilities, and options. Contact us today for a free, no-obligation consultation to discuss the details of your case and how we can help you begin to move forward.