Zimmer Persona Knees
The Food and Drug Administration (FDA) approved the Zimmer Personalized Knee System (Zimmer Persona Knee) in late 2012. Just three short years later, Zimmer implemented a product recall for the Trabecular Metal Tibial Plate, a component of the system, because of reports that it may cause problems requiring revision surgery.
Zimmer announced the recall in February 2015. About 11,658 devices are affected. In addition, the company also recalled the Persona Tibial Articular Surface Provisional Shim, a tool used during knee replacement surgery, because of the potential for problems.
Patients who went through a knee replacement with the Zimmer Persona Knee and later experienced pain, loosening, and other problems are urged to contact a personal injury attorney. Revision surgery can be complicated and often requires a longer recovery than what is typical after an initial replacement surgery. Families may be entitled to compensation to help cover medical expenses.
What is the Zimmer Trabecular Metal Tibial Plate?
According to Zimmer’s advertising materials, the Zimmer Persona Knee was “designed to minimize the compromises experienced with yesterday’s standard knee systems.” The system allows surgeons to personalize the implant to the unique needs of the patient, with a goal of coming as close as possible to the way a real human joint works.
Along with the Persona system, Zimmer provided a variety of component sizes and shapes to allow surgeons to more accurately manage the fitting of the implant. Different components could also be used depending on whether the surgeon was planning on retaining part of the joint or completely replacing it.
The Trabecular Metal Tibial Plate, in particular, is a component that fits over the top of the tibia bone (shin bone) after it has been modified to accommodate the implant. It is secured to the bone, where it provides a sort of platform for the rest of the knee implant.
Why Was the Zimmer Persona Knee Component Recalled?
According to Zimmer, they initiated the voluntary recall after receiving an unusually high amount of reports of problems associated with it. The main two problems reported included:
1. Radiolucent Lines: These are dark areas on x-rays indicating gaps between the device and the bone tissue. These indicate a “poor seating” of the plate, showing that it’s not staying where intended and is coming loose.
2. Loosening: The component itself was loosening from its position. According to Zimmer, “Aseptic loosening of cementless tibial implant components is one of the most prevalent causes for revision in total knee arthroplasty….”
Indeed, according to a 2006 study, radiolucent lines have been associated with early loosening of the knee implant. They also correspond to an increased risk that the implant will fail prematurely.
This type of premature loosening may require revision surgery, which is commonly more complicated than the original surgery and results in more recovery time for patients.
FDA Announces Class 2 Zimmer Persona Knee Recall
In February 2015, Zimmer sent an urgent medical device recall notice to surgeons and hospitals. In it, they alerted medical professionals to the risks. Of the complaints received:
• 36 percent identified symptomatic radiolucent lines or were revised for loosening.
• 28 percent had asymptomatic radiolucencies.
• 8 percent subsided.
• 28 percent were inconclusive.
They added that patients experiencing symptoms because of the implant may have a tibial plate that is not fixated properly to the bone and is causing pain. That the implant “never achieves appropriate biological fixation” is a potential complication that may lead to required revision surgery.
Zimmer advised physicians to work with Zimmer sales representatives to remove the recalled product from medical facilities.
On March 12, 2015, the FDA classified the Zimmer Persona Knee recall as a “Class 2 recall,” which indicates that the device can cause “temporary” or “reversible” harm. The joint loosening is considered “reversible” because it may be corrected through revision surgery, where the surgeon either corrects the issue or replaces the faulty device.
The FDA noted that all sizes and lots of the affected component were being removed from distribution.
Dangers of Zimmer Persona Revision Surgery
Though revision surgery may correct the problems associated with the Zimmer Persona Knee, these surgeries come with their own unique risks. Since the knee has already been operated on once, it is more vulnerable to potential problems from a second surgery.
Such surgeries often require “bone grafting,” in which bone is taken either from another site in the patient’s own body, or comes from a donor. The procedure takes longer than the initial knee replacement, and special tools and implants are required to restore stability.
Though potential complications are similar to those associated with the initial surgery, the risk for these complications is higher the second time:
• Pain and swelling
• Nerve, tissue, or blood vessel damage
• Bone loss
• Blood clots
• Leg length differences
Tens of thousands of revision surgeries are performed each year in the U.S., with the majority proving to be successful, and most patients eventually enjoying positive results. Still, patients who have to go through revision surgery because of negligence on the part of the manufacturer deserve to be compensated for their medical expenses.
Types of Injuries Associated with the Zimmer Persona Knee
Patients who experience problems with the Zimmer Persona Knee may suffer the following symptoms:
• Persistent pain
• Difficulty walking or getting up from a seated position
• Knee instability; the feeling that one may fall
• Knee tightness
In addition to these symptoms, a Zimmer Persona Knee that is coming loose may also lead to the following complications:
• Bone fracture
• Loss of bone tissue; wearing away of bone
• Swelling and inflammation in the joint
• Complete implant failure
Zimmer Persona Knee Approved Through 510(k) Program
The Zimmer Persona Knee implant was approved through the FDA’s “fast-track” approval process known as the “510(k)” program. When using this program, manufacturers do not have to show the FDA through clinical trial results that their product is effective and safe for the public. Instead, they have only to show that the device is “substantially similar” to one that’s already on the market.
This program was put into place to help push needed medical devices onto the market with limited red tape, in the hopes of benefitting patients. Watchdog groups have criticized the 510(k), however, stating that it allows untested and potentially unsafe devices onto the market where they may cause harm.
In 2011, the Institute of Medicine (IOM) suggested the FDA get rid of the program, stating it did not do enough to protect the public. “The IOM finds that the current 510(k) process is flawed…” they stated, concluding that the “FDA’s finite resources would be better invested in” developing a new framework that “provides a reasonable assurance of safety and effectiveness throughout the device life cycle.”
In 2014, the FDA adjusted the program somewhat, but it continues to be available for manufacturers wanting to quickly get their products to market.
Zimmer No Stranger to Joint Device Problems
This isn’t the first Zimmer has faced reports of problems with their joint implants. In 2008, they temporarily stopped sales on the Durom Cup hip implant because of reports of metal contamination and tissue damage leading to premature loosening. Dr. Lawrence Dorr, a paid consultant for Zimmer, alerted physicians to problems with the implant that increased risk of improper fixation.
Zimmer’s NexGen knees were also named in a number of adverse event reports. In 2010, the company recalled nearly 70,000 MIS Tibial components because of risks associated with premature loosening and device failure. That same year, they recalled femoral components used in the LPS system because of manufacturing defects. In 2014, they also recalled 40,000 NexGen Knee implants because of defective screws.
Zimmer has been defending itself in court for years because of claims that their implants resulted in premature complications resulting in a need for revision surgeries.
A Zimmer Persona Knee Lawyer Can Help
If you or a loved one has suffered serious side effects after a Zimmer Persona Knee surgery, the attorneys at Chaffin Luhana LLP may be able to help. Even though Zimmer has issued a voluntary recall for the defective components, that doesn’t absolve them of responsibility for those patients who were injured. The company should have done more to ensure that the implant was safe and effective before subjecting patients to the potential risks.
The company may be in touch with you or your doctor about the recall. Before you sign any papers, it’s best that you protect your rights by speaking to a Zimmer Persona Knee attorney. Call today for a free and confidential case evaluation at 1-888-316-2311.