Patients across the country are concerned over the recent Zimmer Persona tibial plate recall after patients alleged they suffered serious injuries and total device failure.

The FDA announced the Zimmer persona tibial plate recall in March 2015, after receiving reports that the device was coming loose from where it was implanted.

The Zimmer medical corporation announced a voluntary Zimmer persona tibial plate recall a month before the FDA’s announcement, informing the public that the recall affected nearly 12,000 trabecular metal components.

The Zimmer persona tibial plate is a metal component of one of the company’s total knee replacement products. During surgery, the tibial plate is directly implanted into the bone without cement. The Zimmer persona tibial plate is directly attached to the tibia, with two pegs that are inserted into the bone and are supposed to eventually “grow” into the bone.

The pegs of the device are meant to give stability to the knee, as the body adjusts to the implant. However Zimmer and FDA have issued the Zimmer persona tibial plate recall, due to serious allegations of device loosening and total device failure.

The FDA categorized the Zimmer persona tibial plate recall as a “Class 2” recall, which means that the device have caused temporary or reversible harm to patients. According to the FDA, all lots and sizes of the Zimmer Persona Trabecular Metal tibial plate are affected by the recall.

Overview of Zimmer Persona Tibial Knee Implant Complications

Diagnostic images show that gaps between the knee implant and bone are present, which can be an indication of “poor seating.” Poor seating is caused when the plate has moved from its intended implant position, typically caused by the device loosening.

When this occurs, radiolucent lines will appear in x-rays and ultimately show the gaps between the tibial plate and bone. Poor seating can potentially lead to a number of complications, including retention of fluid around the joint.

As the implant wears down, debris can leak into the cracks between the knee implant and the bone. Loose knee implants can cause serious damage to bones, as the implant can cause damage to the tibia while other complaints have alleged the metal plate becomes completely detached from its position.

Revision surgery is currently the only treatment method for patients suffering form Zimmer persona knee implant complications. By one measure, 38% of patients had to undergo revision surgery due to device failure or loosening. Many patients have reported injuries such as: lack of in growth into the bone, loss of bone fixation, instability, and patella tracking problems.

Furthermore, injury reports indicate that patients may have to undergo a second revision surgery in the worst cases, putting patients at higher risk for pain and swelling, infection, blood clots, fractures, and damages to nerves or blood vessels.

Even though the Zimmer persona tibial plate recall helps prevent future knee implant failures, it does not help patients who have already suffered them. Patients who have experienced Zimmer persona tibial plate complications may benefit from a consultation with a knowledgeable medical device attorney.