The Zimmer Persona knee replacement system has been linked to several serious health complications, including damage to nerves and blood vessels as well as bone fractures. The pharmaceutical attorneys with Baron & Budd may be able to help if you have been harmed by this device. Contact us online or call 866-520-2755 to learn more about how we may be of assistance.
How the Zimmer Persona Knee Replacement Works
The Persona knee replacement system, approved by the U.S. Food and Drug Administration (FDA) in 2012, is manufactured by Indiana-based Zimmer Holdings, Inc., which was formed in 1927. The Zimmer Persona system is a prosthetic knee device made of several components and designed for people who are experiencing severe, debilitating knee pain. Many people suffering from rheumatoid arthritis and osteoarthritis are candidates for the device.
In addition to the Persona system, Zimmer manufactures several knee replacement system components that come in a variety of shapes and sizes. One of these components, the Trabecular Metal Tibial Plate, fits over the top of the patient’s shin bone, or tibia, and is then secured to the area. This provides a platform for the remainder of the system.
Zimmer’s advertising material claims that the system facilitates more natural motion of the knee, coming as close as possible to simulating the mechanics of the knee joint. The device is designed to help restore a patient’s mobility while alleviating pain to improve quality of life.
Complications Associated with the Zimmer Persona
Patients have reported several health complications after having the Persona system implanted, including loss of mobility, persistent pain, and swelling . In some instances, issues included damage to blood vessels and nerve tissues, as well as fractures that occurred when pieces of the device became detached. Patients have also reported failure of the implant, resulting in loosening of the joint and device dislocation.
X-rays taken of patients implanted with the Persona system have, in some instances, shown radiolucent lines, an indication that the device has become loose. The Persona Trabecular Tibial Plate has been identified as a main cause of loosening, resulting in gaps between the device and surrounding bone. This can result in instability, leading to immobility and the potential of additional injury, such as osteolysis. Osteolysis is a complication that occurs when the wear-and-tear of the implant produces debris that becomes embedded between the cracks of a loose implant and bone, resulting in bone damage.
The system has, in some cases, failed to the point that a revision surgery is needed. The appearance of radiolucent lines can be an indication that the device needs to be revised or completely replaced. Total replacement involves an additional surgery to remove the original device and replace it with a new one. This additional procedure is often extremely painful and even more debilitating than the first one, resulting in a substantially longer recovery time and a heightened risk of further complications.
Zimmer Persona Knee Replacement FDA Recall
In March 2015, the FDA issued a Class II Recall of more than 11,600 Persona Trabecular Tibial Plate devices. The company had previously sent a notice to healthcare providers and hospitals in February 2015, instructing them to locate and quarantine all devices that had not been implanted. A Class II recall occurs when the FDA determines a product can cause adverse health complications that are reversible. In this case, the agency determined that the damage is reversible because a revision surgery can be used to replace an implant that has malfunctioned.
Filing a Zimmer Persona Knee Lawsuit
The Persona system replaced Zimmer’s previous knee replacement device known as the NexGen. The FDA granted approval to the Persona through its 510(k) process, which allows the manufacturer of a new device to claim that the new device is not substantially different from other pre-existing products that are already available on the market. The 510(k) process is a “shortcut” of sorts, allowing a manufacturer to bring a device to market faster because it forgoes the need for both expensive clinical trials and testing on humans.
Just because the FDA found that the damage caused by a faulty Persona knee replacement system is reversible, that does not mean Zimmer can avoid accountability for the device’s shortcomings.
In some recall cases, manufacturers will reach out to patients who have had a potentially defective medical device implanted. Typically, these manufacturers are simply trying to advise patients of the recall or ask for basic medical information. However, it is not uncommon for manufacturers to attempt to offer a settlement to avoid the hassle and expense of litigation. In order to accept a settlement, a patient must sign a document releasing that manufacturer from any and all liability. Patients who sign these documents will have no legal recourse – and will not be eligible to pursue further compensation.
If you or a loved one has received a Persona knee replacement it is important that you speak with an attorney before having any conversations with the manufacturer. By filing a lawsuit, instead of accepting an unfavorable settlement directly from the manufacturer, you may be entitled to compensation for your medical expenses related to your injury, as well as the ability to claim damages for your pain and suffering.
How Baron & Budd Can Help
If you or a loved one had a Persona knee replacement system implanted and suffered adverse health complications as a result, Baron & Budd may be able to help. Never disclose any health information, and never accept any type of settlement offer before talking to a lawyer first. If you would like to learn more about how we may be of assistance, please complete our contact form or call 866-520-2755.