Any sort of faulty or defective product could potentially be harmful to the user, but defective medical devices are particularly dangerous. When you use a medical product or device, you have a right to expect a certain level of safety and effectiveness. However, if a medical device is defective, either by design or in the manufacturing process, the company that produces that product could be liable. The Zimmer Persona Knee System is a prosthesis created with the intention of helping individuals suffering from severe knee issues, but it has since been proclaimed as anything but a success.
The Zimmer Persona Knee System was first approved for U.S. markets in 2012, as a 510k device. As a prosthesis, the device filled in for knee joints damaged by arthritis, injury, or some other type of damage. The 510k process, which was enacted by the FDA, allows certain products to enter the market without required testing if they are similar to other products currently approved and on the market. However, the FDA recalled the Zimmer Persona Knee System only a few short years later, in 2015, after receiving many complaints of defective knee implants.
A portion of the Zimmer Persona Knee System has lately proven defective. The tibial component of the knee system, which was included in approximately 11,000 of the Zimmer Persona systems, allowed for poor fixation due to a product flaw. This issue often caused loosening of the device, and led to the appearance of radiolucent lines, which act as a warning sign of premature failure of the device. While not all of the Zimmer Persona Knee Systems used the defective tibial component, thousands were impacted by the device failure, resulting in severe pain and potentially the need for a revision surgery.
Individuals who received knee surgery with the Zimmer Persona Knee System with a tibial component should look for warning signs of device failure or malfunction. The first indication of device failure is typically pain in the affected area, and a loose feeling in the joint. Individuals might also feel decreased mobility in the knee joint, as well as other complications affecting the surrounding bone and tissue.
If you were affected by a faulty Zimmer Persona Knee System, you may be eligible to seek compensation. These defective knee implants may cause physical discomfort, pain, and in severe cases may require revision surgeries, which can be costly and inconvenient.
To discuss your case with our defective medical device attorneys, contact Kaiser Gornick, LLP.