Knee replacement surgery is rather common. But, sadly, knee replacement lawsuits happen just as frequently. The number of patients who require surgery because of defective artificial knees has doubled in the last ten years.
Knee surgery is especially common in patients aged 45 to 64; and with aging Baby Boomers now undergoing such operations, knee replacement has become a multi-billion-dollar industry.
Many who have gotten artificial knees are discovering – the hard way – why these devices were designed to last only five to ten years. Replacement knees were created for senior citizens who are not as mobile as younger people but who have many “active” years left. Most of these devices were never tested for longer-term patient use. Nevertheless, based on the recommendation of their doctors and device manufacturers, many submitted to the procedure, assuming the devices would last a long time. Little did they know.
Some of the devices weren’t even tested for short-term use either. Yet many faulty replacement knees or defective components were fast-tracked through the Food and Drug Administration’s (FDA) approval process. It’s a little-known fact that medical device manufacturers can apply to the FDA for a 510(k) premarket program that allows them to bring a device to market with limited testing if there is a similar product already on the market.
Many knee replacement devices approved through this program are now failing at shockingly high rates. This is exposing an oversight malfunction in the FDA’s regulatory system. But a large amount of blame should also be laid at the feet of the medical device companies themselves, who use FDA “fine print” to hastily release medical devices without regard for patient safety.
Defective Knee Replacement Devices and Their Expensive, Painful Complications
Patients with faulty or failed knee replacement devices suffer a variety of medical issues, which can include the following:
- Persistent pain, swelling, and joint stiffness
- Deep vein thrombosis (blood clots)
- Device failure within five years of replacement, some as little as two years
- Nerve injuries
- Chips, fractures, or migration of device components
- Infections at the affected joint which could be limb- and life-threatening.
Many patients experience chronic pain so severe that repair procedures cannot give back their normal, active lives, leaving them worse off than they were before the original replacement surgery.
Defective Device Lawsuits
In response to the complications suffered by many knee replacement recipients, lawsuits have been filed against joint replacement device manufacturers.
One case we’re familiar with was filed by a woman after she received a Zimmer Biomet NexGen knee device in 2009. Within two years she began suffering painful complications and needed revision surgery. During the procedure, she then suffered intra-operative bleeding. This forced her transfer to another hospital for yet another operation – one that never would have been needed had her original artificial knee worked as promised
Often, multiple replacement procedures – accompanied by painful recovery – are necessary to correct an original knee replacement surgery. Hundreds of injured plaintiffs have filed lawsuits claiming their devices did not work as promised. So far, well over 600 such civil suits have been filed against NexGen manufacturer Zimmer, seeking compensation for medical expenses, rehabilitation, home health care, loss of income, pain, suffering, and temporary or permanent disability.
Zimmer was also the defendant in a lawsuit filed by the Securities & Exchange Commission which alleged the company bribed surgeons with paid consulting agreements for using their products. Zimmer had to pay almost $170 million to settle those charges.
Many Knee Replacement Device Manufacturers Are Dealing with Lawsuits
Zimmer is not the only company facing civil action because of its faulty knee replacement devices. A DePuy Attune Knee, which has a five-year failure rate of nearly 68 percent, is also the target of several investigations. Other companies have issued recalls on many of their devices, too, and are facing multiple insurance claims and civil lawsuits. A few of these firms include:
- Exactech’s Optetrack Knee
- Stryker’s Scorpio CR and PS components, Unicompartmental Knee System, and Duracon Total Knee
- Smith & Nephew’s Oxinium Genesis II, Profix II, and Journey Uni Tibial Baseplate components
- Biomet’s Vanguard CR.
We must also tell you that many of these companies who are having difficulty with their artificial knees are experiencing similar problems (and civil injury lawsuits) with their hip replacement systems — and for the same reasons.
Why Should You File a Knee Replacement Lawsuit?
Injured patients who file knee replacement lawsuits are likely suffering an assortment of medical complications related to their device, including:
- Inflammation or knee swelling
- Joint damage
- Bone, muscle, or nerve damage in the knee area
- Popping, clicking, or crunching sounds near the device
- Issues with walking or standing.
If you’ve undergone a knee replacement surgery and now suffer painful and/or functional complications, chances are you will never fully regain your lost mobility or attain 100 percent knee health. But filing a lawsuit can help ease the financial burdens caused by a malfunctioning device and give you a sense of justice. Knee replacement lawsuits also draw attention to these defective products; hopefully enough of them can build a fire under the FDA causing it to be more diligent in its medical device approval process.
If you or a family member has had to undergo revision surgery for a failed knee replacement or have been told you need knee revision surgery, please contact Terry Bryant Accident & Injury Law to arrange your free consultation.