A Zimmer Persona knee implant recall could affect you if you have had failed knee replacement surgery.

Zimmer Biomet issued a voluntary recall of the Zimmer Persona Trabecular Metal Tibial Plate in February 2015. A month later, the FDA announced it as a Class 2 recall.

The metal tibial plate connects to the bone without cement. Instead of using cement, the part has two pegs designed to be inserted directly into the shin bone, known as the tibia. The pegs were designed to stimulate bone growth, intending for the bone to act as a natural stabilizer, something Zimmer refers to as “biological fixation.”

Zimmer Persona Knee Implant Recall on Uncemented Parts

This Zimmer Persona knee implant recall sheds light on several issues.

First, the device went through the FDA’s fast track program that allows devices that are “substantially equivalent” to something already on the market to be FDA-approved without the same clinical trials that a “new” device would need to endure.

The porous-coated tibial plate supposedly allowed uncemented biological fixation to hold the components in place. However, X-rays that show gaps between the tibial plate and the bone indicate “poor seating.” Radiolucent lines that show the plate has moved from its originally intended position can indicate poor seating and that the implant has become loose.

Poor seating can lead to many problems, including fluid retention around the joint. As metals in the implant wear down, the tiny pieces of metal can make their way into the cracks between the implant plate and the bone.

Zimmer claims 38 percent of patients who had failed Persona plates had radiolucent lines or underwent revision surgery due to failed parts in the Zimmer knee replacement recall.

Those suffering from parts covered by the Zimmer Persona knee implant recall will often find a second knee surgery is difficult to endure. A recurrent knee surgery leaves a patient at higher risk for pain and swelling, infection, blood clots, bone loss, fractures and nerve, tissue or blood vessel damage.

Because bone has already been disrupted and traumatized by the initial surgery, the bone could need bone grafting in order to complete a second surgery successfully. Bone either is taken from another part of the patient’s own body or is obtained from a donor. Repeated surgery can also lead to a discrepancy in the length of the patient’s legs.

Nearly 12,000 units are covered by the Zimmer Persona knee implant recall, which does not include any implants that were set with cement.

If you’re unsure whether your knee implant is covered by this recall notice, there are ways to find out. You can check an X-ray if you have a copy of one. You will see the pegs on the bottom of the metal plate that attach to the tibia. If you still are unsure, an attorney who has experience with Zimmer Persona knee implant recalls can help you determine if your implant is affected by this recall.