Zimmer Persona® Trabecular Metal™ Tibial Plate Knee Implant Recall
When the world’s largest knee replacement manufacturer issues a recall, people take notice. You may have already heard about Zimmer’s Persona® product – a knee implant designed to fit with each patient’s body, providing a fuller range of movement and a better quality of life. For some patients, the new knee provided just the opposite. After numerous complaints of pain and mobility issues, and medical findings of radiolucent lines and loosening, Zimmer, Inc. issued a voluntary recall of the Persona® Trabecular Metal™ Tibial Plate. On February 16, 2015, the company sent a notice to hospitals and device distributors urging them to return every recalled product immediately.
The FDA Recall
Later, on March 12, 2014, The Food and Drug Administration (FDA) issued a Class II recall for the Zimmer Persona® Trabecular Metal™ Tibial Plate knee implant. A Class II Recall is issued for products that may “cause temporary or medically reversible adverse health consequences.” According to the FDA, a total of 11,658 devices were recalled.
In some cases, the tibial component of the Persona® Trabecular Metal™ Tibial Plate was found to loosen gradually after implantation. After knee replacement surgery, affected patients began to complain of pain and mobility issues, leading their doctors to order imaging tests. Many tests found radiolucent lines, indicating space between the device and the bone. These images indicated that the devices were loosening, leading to a range of issues for patients, including:
- Swelling and pain
- Damage to surrounding tissue
- Osteolysis (bone damage)
This loosening may requires a patient to undergo revision surgery – removing and replacing the tibial component of the knee. After issuing recalls on other devices, Zimmer set aside millions of dollars to help cover patients’ revision surgeries. As an affected person, you may have the right to pursue legal help and seek compensation for your lost wages, pain, and unplanned medical bills.
Pursuing a Zimmer Knee Lawsuit?
Have you or a loved one been severely impacted by this Zimmer recall? Ward Black Law in Greensboro, N.C., can provide a free and confidential case review. We have helped patients suffering from defective medical device injuries for decades. With decades of experience and a passion for serving people, we will act as your powerful voice, fighting for the recovery you deserve.
Call us at (336) 333-2244 or toll-free at 1-877-256-1214. You may also reach Ward Black Law by online inquiry.