In 2014, the Zimmer Persona knee replacement device was a huge moneymaker for the company, bringing in approximately $2 billion of the company’s $4.7 billion in net sales that year.

The Persona was released by Zimmer in 2012, adding it to the half-dozen or so other knee replacement systems currently on the market at the time. The product itself was seen as a superior one when it was released due to its excellence in a precision anatomical fit that it has offered many patients.

However, on March 12, 2015, the FDA released a statement that Zimmer had issued a voluntary recall for the the “Zimmer Persona Trabecular Metal Tibial Plate/Persona TM Tibia-Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer” devices. The Zimmer knee replacement recall affected both the left and right knees in sizes C through J.

This recall was classified as a Class II recall which the FDA describes as follows: “Class II Recall is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

According to the FDA statement, Zimmer voluntarily recalled the device due to “an increase in complaints of radiolucent lines and loosening.” Zimmer sent recall notices to hospitals, surgeons, and distributors via mail on Feb. 16, 2015.

Patients were complaining of knee pain following their total knee replacement, and at that time the company began investigating these complaints. It was determined that the product was loosening when it was placed within the knee. The loosening could also can cause a reduction in the range of motion, unstable balance, difficulty walking or moving the knee, and popping in the joint, in addition to generalized knee pain.

Approximately 11,000 units were subject to this recall. Patients who were affected by the allegedly defective device had to go on to have surgery to repair or replace the faulty implant.

Zimmer’s knee products represent its largest product group. In an annual report that was released regarding the company’s 2014 performance, Zimmer stated, “Our Knee product category has benefited from recent product introductions, such as Persona The Personalized Knee System and joint preservation solutions. However, the volume/mix growth from new product introductions has been tempered by pricing pressure in all our reporting segments.”

Filing a Lawsuit over the Zimmer Knee Replacement Recall

If you are a patient who had the Zimmer Persona Trabecular Metal tibial plates used without cement during your knee replacement surgery from March 2012 to March 2015 and your medical device was the subject of the Zimmer knee replacement recall, you may be entitled to legal compensation.

Patients who file claims over allegedly defective medical devices can often recover damages related to medical costs, loss of earnings and earning capacity, loss of spousal companionship and more. Many plaintiffs not only get compensation for what they may have lost but also hold companies accountable for producing allegedly defective devices.

An experienced attorney is available to review your case at no charge to you. If you qualify, you can receive additional information on pursuing the legal options that are available to you.