When someone needs a knee replacement, they expect to have a device implanted that will withstand normal wear and tear. However, a recent Zimmer tibial plate recall has knee replacement patients wondering if they made the right choice.

Zimmer, a medical device company based in northern Indiana, manufactures a product called the Zimmer Persona Trabecular Metal (TM) implant. The difference between this knee implant and others is the use of a component called a tibial plate.

This tibial plate is implanted directly into the tibia bone without the use of cement. It has two pegs that are implanted into the bone and will “grow” into place to give the implant stability.

The Zimmer Persona device is recommended for those who need knee replacement due to severe knee pain or disability. This can include conditions such as rheumatoid arthritis, osteoarthritis, collagen disorders, post-traumatic loss of joint configuration, inability to straighten the knee, flexion instability and failed surgical attempts to save the knee.

Even though doctors and patients have had success with the Zimmer Persona device, there have been reports of severe problems with the knee implant.

Early in 2015, Zimmer announced its Zimmer tibial plate recall. The company had begun receiving reports that the implants could loosen early and cause major complications. According to Zimmer, this recall is voluntary.

The U.S. Food and Drug Administration (FDA) announced this Zimmer tibial plate recall  as a Class II recall for all lots and sizes of the device. Nearly 12,000 knee implant components fall under this Zimmer tibial plate recall.

While a Class II FDA recall is not considered as serious as other classes of recalls, it still indicates a “violative product [that] may cause temporary or medically reversible adverse health consequences.”

The Zimmer tibial plate recall was based on reports of two types of complications: radiolucent lines and loosening.

Radiolucent lines in connection with a knee replacement occur when an X-ray shows gaps between the implant and the bone. This is a sign that the implant has moved from where it was intended to be.

This movement is a precursor to loosening. Loosening happens when the metal plate comes loose from where it was originally attached. This can signal a need for a complete revision surgery.

Many patients affected by the Zimmer tibial plate recall have had to undergo revision surgery because of complaints of persistent pain, loosening of the device, lack of ingrowth, component failure, loss of fixation, globally tight knee, instability, fracture or patella tracking issues.

If you or someone you love has been affected by the Zimmer tibial plate recall, you may benefit from speaking with an experienced attorney.