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The attorneys at Franklin D. Azar & Associates are actively investigating reports of problems with the DePuy Synthes ATTUNE Knee System, a knee replacement device developed for patients suffering from chronic knee pain. Since DePuy began marketing the device in 2013, the Food and Drug Administration has received numerous reports of “adverse events” involving the product.

How Many People Have Gotten Knee Replacements?

Roughly ten percent of Americans carry a medical device of some kind implanted in their bodies, ranging from pacemakers and artificial joints to surgical mesh and birth-control devices. Some procedures, such as knee replacement, have become so common that more than 600,000 people undergo the surgery every year in this country, usually to relieve chronic pain from arthritis.

About DePuy and DePuy ATTUNE

In many cases, the procedure is successful. DePuy, a company that is part of Johnson & Johnson’s medical devices group, is one of the world’s largest manufacturers of knee implants and has developed more than a dozen different knee systems. It has described the ATTUNE Knee System as a “state-of-the-art” device that offers greater range of motion sooner to patients recovering from knee replacement surgery than competing products.

However, a 2017 article in the Journal of Knee Surgery, authored by several orthopedic surgeons, remarked on what they considered to be an unusual number of early failures of the ATTUNE Knee System, a phenomenon that the authors attributed to a “high rate of debonding” between the tibial component and the bone cement used to hold it in place. (In other words, the glue used to hold the device in place wasn’t adhering to the tibial component.) The publication of that article was soon followed by the filing, in Alabama, of a DePuy knee replacement lawsuit, the first of what could turn out to be hundreds of lawsuits claiming that the product is defective.

The researchers who conducted the study reviewed clinical and radiographic data for patients who were implanted with the ATTUNE system and later required revision surgery. They found in one database 21 reports over a two-month period of tibial loosening at the implant-cement interface, and numerous other reports of tibial failure that weren’t specific about the mechanism of failure. The authors believed that the complication was probably underreported.

DePuy ATTUNE Tibial Loosening Symptoms

Patients who experienced the “debonding” problem— in some cases, within two years of having knee replacement surgery — complained of side effects such as pain, swelling, inflammation, and difficulty walking. They also faced the prospect of a painful revision surgery, followed by weeks or months of physical therapy and rehabilitation. In two case studies cited in the article, the doctors who performed the revision surgeries examined the devices that they removed and found no evidence that the cement had ever adhered to the tibial plate.

DePuy responded to the article with its own white paper, challenging the authors’ methods and conclusions. The company has strongly denied any defects in the DePuy ATTUNE Knee System and has declined to issue a recall; at the same time, it has launched a new version of the tibial base plate, the ATTUNE S+, that is supposed to offer improved bonding ability.

Finding a DePuy Lawyer

If you or a loved one have suffered injuries or undergone revision surgery as a result of DePuy ATTUNE Knee failure, you may be entitled to compensation for your pain, emotional distress, lost wages and even out-of-pocket expenses that you may have incurred.

Knee replacement lawsuits are usually filed individually and are not class actions. Our product liability attorneys have years of experience litigating cases involving defective devices.

Contact us for a free, no-obligation consultation. We represent people that are injured by defective medical devices on a contingency fee basis, so that you do not pay anything unless your case wins/settles.

Previous DePuy Knee Recalls and Lawsuits

This isn’t the first time DePuy has felt the need to retune, so to speak, its ATTUNE technology. In 2015 it launched a global recall of 3,474 units of its ATTUNE Knee Tibial Articulation Surface instrument, a device used to measure a patient’s “fit” prior to implanting an artificial knee. According to the recall notice, there was potential for a small wire spring on the device “to become damaged and disassociate (come off).” If that happened, it was possible that the spring would be left inside the patient after the surgery.

The company has also faced litigation from thousands of patients over certain artificial hip implants. One, a metal-on-metal device known as the ASR XL, began to generate complaints not long after it hit the market in 2005, including reports of the device shedding debris and causing infection, injury, nerve damage, and metallosis, a type of metal poisoning that can lead to bone loss, tissue damage, and other serious complications. Despite mounting adverse reports, DePuy didn’t stop selling the model until 2010. (The company blamed poor sales, not a product defect, for the decision.) Thousands of lawsuits against that product and a subsequent DePuy hip implant, the Pinnacle, are now underway, including 9000 cases filed in multidistrict litigation in the Northern District of Texas. One bellwether trial over the Pinnacle implants resulted in a $247 million jury award for six patients who had to have their hips surgically removed; two previous trials resulted in jury verdicts of $502 million and $1.04 billion (later reduced to $150 million).

The high-stakes medical device industry receives far less scrutiny from federal regulators than most consumers realize. “Many people assume that the Food Drug Administration requires rigorous testing of medical devices before they are approved,” notes Jeanne Lenzer, author the The Danger Within Us, in a recent opinion piece in the New York Times.“ In fact, most high-risk devices on the market, including implants, have undergone no clinical testing at all.”

Lenzer observes that medical device makers can skirt clinical testing by representing that their products are “substantially equivalent” to ones already in the marketplace or that they contain only minor modifications. But if those changes result in a dangerous defect or failure, it’s often not detected until after the device has already been implanted in many patients, a population that effectively becomes “unwitting guinea pigs.” Partly as a result of the ease with which such devices now reach the marketplace, the number of Class 1 device recalls (the most serious form of recall) has soared to more than ten times what it was in 2003.

If you have suffered injuries or undergone revision surgery as a result of failure of a defective medical device, you may be entitled to compensation. The product liability attorneys at Franklin D. Azar & Associates can help answer your questions concerning several devices associated with recalls, adverse events, or possibly inadequate warnings issued to doctors and patients, including Pinnacle Hips, ATTUNE Knee Systems, St. Jude Defibrillators, and faulty shoulder replacements. Contact us for a free, no-obligation consultation.


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