Patients who’ve received a total knee replacement do not expect to need revision surgery. However, that just may be the case for some knee replacement patients following an FDA Zimmer knee recall announcement that classified a voluntary recall by the manufacturer as a Class II recall.

Zimmer Biomet was founded in 1927 and is the largest knee implant maker in the world. It is headquartered in Northern Indiana and manufactures the Zimmer Persona Knee System, which includes a component known as the “Zimmer Persona Trabecular Metal tibial plate.”

Recently, an FDA Zimmer knee recall announcement was made advising consumers that the federal agency was giving a “Class II” designation to a voluntary recall of the tibial plate by Zimmer Biomet. The company issued the recall  in response to growing numbers of adverse event reports associated with the medical device. The Class II recall affects nearly 12,000 devices.

The FDA has said Zimmer Inc. is initiating a voluntary recall of the Zimmer Persona Trabecular Metal tibial plate following an increase in complaints of radiolucent lines and loosening. “All sizes and lots of the affected [knee implant] devices are being removed from distribution.”

A Class II recall is issued if the FDA deems a product to potentially cause temporary or medically reversible complications. Even though this is not the most serious of recall categories, the FDA Zimmer knee recall is still concerning for patients and medical professionals.

The metal tibial plate component of the Zimmer Persona Knee Implant is implanted into the bone without cement. Its two pegs are inserted into the bone, and then the bone is expected to grow around the pegs, securing the knee implant in place.

The FDA mentions radiolucent lines in its FDA Zimmer knee recall. Radiolucent lines are large gaps between the components of the knee replacement itself or gaps between the bone and the metal knee components.

These gaps can cause many complications. Fluid can build up and both the tissue and the implant may wear away and cause debris to lodge in the radiolucent lines.

This can lead to damage of the bone and loosening of the implant. When the implant loosens, severe pain and swelling may occur.

These problems often lead to the need for revision surgery. In revision surgery, the joint components or the entire implant must be replaced. Revision surgery is more difficult and comes with more potential complications than the original joint replacement surgery.

Zimmer has said that of the complaints it has received about their Zimmer Persona Knee Implant, 38% dealt with radiolucent lines or the need for revision surgery.

Symptoms leading up to revision surgery include:

• Persistent pain
• Loosening of device
• Lack of ingrowth
• Component failure
• Loss of fixation
• Globally tight knee
• Instability
• Fracture
• Patella tracking issues

If you or someone you love has been implanted with a Zimmer knee implant and may be affected by the FDA Zimmer knee recall, you may benefit from speaking with an attorney.