Zimmer Recalls Persona Knee Implant, Patients Seek Compensation
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UPDATED: May 4, 2015
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A component of a knee replacement product known as the Persona total knee replacement system has been recalled by the manufacturer. Patients who have had a knee replacement using the Persona implant may need further surgery to avoid the risk of product failure or to correct problems caused by the loosening of the implant. Those patients may have the right to receive compensation.
Why do people need knee implants?
The knee joint is behind the patella (kneecap). Four ligaments act like ropes that tie the bones of the upper leg (the femur) to the bones of the lower leg (the tibia and fibula) while holding the patella in place. Tendons in the knee connect leg bones to leg muscles (including quadriceps and calf muscles). Tissues called cartilages act as a buffer to prevent the bones from grinding together when you squat or sit and from banging against each other when you run. Pockets of fluid (bursae) and fat pads provide additional cushioning, reducing friction and acting as “shock absorbers” when you run or jump.
While the knee joint is shielded by the patella, it is easily injured. Impacts during car accidents, falls, or athletic competitions can twist the knee or cause it to bend in the wrong direction. Wear-and-tear over the course of a lifetime of running and jumping can also damage the knee joint. Obesity places extra stress on knee joints. Some diseases and hereditary conditions, including various forms of arthritis and avascular necrosis (bone death), can cause knee joint pain and limited mobility.
People with knee problems may find it difficult or painful to climb stairs, to squat, and to kneel. Even walking and sitting can be painful. Some people with arthritis experience constant knee pain even when they are resting. Medication and knee supports are used to treat knee problems but some knee injuries and degenerative diseases do not respond to conventional treatment.
Surgical procedures may be able to repair torn cartilages or ligaments, but some knee joint damage is beyond repair. In severe cases, a doctor may recommend replacement of the knee joint with a knee implant.
What is a knee implant?
Knee replacements restore mobility to the knee, reducing or eliminating pain and allowing patients to live a more active life. Patients who have a knee replacement cannot run or jump without risking damage to the knee, but they can usually walk normally.
During knee replacement surgery, a surgeon removes damaged cartilages and bones and replaces them with an artificial joint that is made of metal and plastic. A surgeon may replace part of the knee joint or may recommend a total knee joint replacement. Patients who receive knee implants are typically between the ages of 50 to 80 but younger people with severe knee problems also opt for knee joint replacements.
Knee implants typically have metal and plastic pieces that attach to the ends of the femur (thigh bone) and tibia (shinbone). Another plastic piece is attached to the patella. Bone cement is often used to hold the three pieces in place although some new technologies do not rely on cement.
A number of different implants are available. A surgeon can choose the implant that is best suited to the patient’s age, size, gender, activity level, and knee problem.
Why was the Zimmer implant recalled?
Headquartered in Warsaw, Indiana, Zimmer designs and manufactures musculoskeletal health care products. Its focus is on joint replacement technology.
Among the products that Zimmer manufactures is the Persona knee, which it advertises as a personalized knee system. The Persona knee replacement system is a follow-up to the company’s NexGen knee replacement system. The effectiveness of Persona in comparison to NexGen is currently being studied.
Zimmer decided to recall a component of the Persona knee replacement system — the Persona Trabecular Metal Tibial Plate — after it became aware that the product was loosening after surgical implantation. In other words, the plate was not staying in place. Zimmer sent Urgent Medical Device Recall notices to distributors, hospitals, and surgeons on February 16, 2015, directing them to quarantine the product immediately so that it would not be used in future surgeries.
Remarkably, consumers who search the Zimmer website for the word “recall” will be directed to a page that bashes personal injury lawyers for their allegedly “misleading” advertising. The Zimmer page is itself misleading in three ways
- The page talks about the NexGen knee replacement system. It never mentions the Persona system. The 2015 recall (which the website ignores) involved a Persona product, not a NexGen product.
- The page states that the Food and Drug Administration (FDA) “never ordered a recall” of any NexGen knee replacement products. Zimmer never mentions that it made a voluntary recall of the Persona product. For reasons that relate to public relations and minimizing their exposure in lawsuits, companies often recall products voluntarily before waiting for the FDA to order a recall.
- Although the page deals only with the NexGen system, it neglects to mention that more than 1,200 lawsuits are pending against Zimmer for the premature failure of its NexGen knee replacements.
You won’t hear it from Zimmer, but the recall is real. It affects more than 11,000 devices that Zimmer sold to health care providers and product distributors. How many of those have already been implanted into patients is unknown.
What problems might patients experience?
Patients with Persona implants have experienced radiolucent lines and an early loosening of the product. A radiolucent line is essentially a gap. When a knee replacement product does not stay where it belongs, a gap between the product and the bone to which it should be attached (or between product components that should be attached to each other) can be seen on X-rays.
When a knee replacement component loosens, patients may suffer from:
- Bone damage
- Tissue and muscle damage
- Severe pain
- Swelling in the knee
- Loss of mobility
Loose components can also cause decaying pieces of bone, as well as fluid and tissues, to work their way into the gap. That problem can lead to osteolysis, a condition that occurs when bones wear down and become thin or weak.
A loosening of the Persona product may require surgical correction. Revision surgery usually involves removing the defective product and replacing it with a different implant. Revision surgery is more complicated than the original surgery and is more likely to produce complications later in the patient’s life.
Are patients entitled to compensation?
If you received a Persona knee implant, you should talk to a personal injury lawyer who is accepting cases against Zimmer. A lawyer can evaluate your case and determine whether you are entitled to compensation as a result of Zimmer’s defective product.
You might be entitled to compensation for:
- The expense of a surgical revision and follow-up medical care.
- Damage to your bones caused by the product’s failure.
- Any disability you experience (such as limited mobility) as a result of the product’s failure.
- Your pain, suffering, mental anguish, and loss of enjoyment of life.
To learn whether you should receive compensation, visit with a personal injury attorney who is familiar with the lawsuits that have already been filed against Zimmer.