April 1, 2016 – San Diego, CA Total knee replacement surgery has become increasingly common in the United States, with the Centers for Disease Control and Prevention (CDC) estimating about 719,000 were performed in 2010.
During total knee replacement (also called total knee arthroplasty or TKA) surgeons replace parts of the knee joint with a prosthetic made of metal, plastic and polymer to help relieve pain and increase mobility. Successful knee replacement surgeries can help patients get back to a more active lifestyle with less pain.
Why do people need knee replacements?
Most often, patients undergo knee replacement surgery because of severe pain and lack of mobility brought on by osteoarthritis or other degenerative joint conditions.
Osteoarthritis is the most common form of arthritis and affects about 27 million adults in the United States, according to the CDC. Osteoarthritis occurs when the cartilage between joints wears down over time, causing pain and stiffness, especially in the hip, knee and fingers. This painful condition affects older adults most often.
Symptoms of osteoarthritis include:
- Pain in the joint during or after movement
- Tenderness of the joint when light pressure is applied
- Stiffness, especially upon waking in the morning or after periods of inactivity
- Loss of flexibility in the joint
- Grating sensation
- Bone spurs (extra bits of bone that may form around the affected joint)
Osteoarthritis worsens over time and can become severe enough to make daily activities, such as walking, climbing stairs and getting in and out of chairs, difficult and painful. When the pain becomes debilitating, doctors may suggest joint replacement surgery.
Knee replacements boast high success rates
The American Academy of Orthopedic Surgeons estimates that of all the knee replacement surgeries performed in the U.S. each year, about 90 percent result in significantly less pain for patients.
Complications from knee surgeries do arise, but are considered rare. Those complications can include infection and blood clots. Implants also do not last forever. Eventually parts wear out and need to be replaced, but it is estimated up to 85 percent of artificial knees still work after 20 years.
With such longevity, it may seem surprising that numerous patients who received a newly designed device by one of the largest orthopedic device manufacturers in the world reported device failure not long after surgery.
Patients report complications; Zimmer Persona recalled
Zimmer Inc., based in Warsaw, Ind., was founded more than 80 years ago is now one of the largest orthopedic device companies in the world.
In the 1990s, Zimmer introduced a line of total knee replacement devices which helped pave the way for newer versions of its prosthetics that did not require clinical data for U.S. Food and Drug Administration (FDA) approval.
Nearly two decades after its NexGen line was introduced in 1995, Zimmer introduced a new total knee replacement device it touted as “the most anatomically accurate knee implant” ever made. The company said its goal was to come as close as possible to the remarkable mechanics of the human body. Its new knee implant was going to “put the person back in knee replacement.”
The Zimmer Persona was approved by the FDA through its 510(k) approval process in March 2012. Three years later, in May 2015, the FDA approved an uncemented version of the Persona device.
Within months, however, Zimmer began to recall an uncemented replacement device called a Trabecular Metal Tibial Plate. Zimmer initiated the voluntary recall in January 2015, and the FDA followed with a class II recall of the device in March 2015. Over 11,000 products were on the market at the time and the recall is still ongoing.
Zimmer initiated the recall after complaints of the device loosening after surgery and causing radiolucent lines began to pour in. Both loosening and radiolucent lines are considered signs of early device failure. Radiolucent lines, which are tiny cracks between the device and the bone where fluid and debris can get trapped, can also lead to bone loss, a condition called osteolysis.
Revision surgery to replace prosthetic knees is more complicated than the initial surgery and is not always as successful.
Patients who received the Zimmer Persona device reported experiencing several adverse effects following the surgery and many required a revision surgery to replace the device.
Complications and side effects of Zimmer Persona knee implants include:
- Severe pain
- Decreased range of motion in joint
- Difficulty putting weight on knee
- Bruising and infection around the knee
Zimmer Persona Lawsuits
Over a thousand lawsuits have been filed against Zimmer after the recall was announced last year. Patients who received the uncemented device may be eligible for financial compensation. Contact the Hood National Law Group today at 1-800-214-1010 for a free case evaluation to see if you qualify, or use the form on the right-hand side of your screen.