The Zimmer Persona tibial plate is one of a long list of medical devices subject to manufacturer recall.

Many of these devices were not completely tested before being given FDA approval, if they were studied at all. This is because of a controversial loophole in the law, known as 510(k) Premarket notification.

While this law may have been well-intentioned, it has been abused by medical device manufacturers that are attempting to get their devices, such as knee replacement systems, on to the market as quickly and cheaply as possible.

Here are some common questions about the Zimmer Persona knee replacement and why its tibial plate has been recalled.

What is the Zimmer Persona Knee Replacement?

The Zimmer Persona is a prosthetic device, based on the company’s previous model, the NexGen knee replacement.

Designed to mimic the natural movements of the human knee joint, the Zimmer knee replacement device was intended for younger and more active patients, and designed to last longer than the usual 20 years. It was approved by the FDA in 2012.

What Went Wrong?

Since its initial approval, the Zimmer Persona knee replacement has been the subject of several reports of premature failure. Specifically, the tibial plate was coming loose from the bone tissue into which it was implanted. When this happens, patients must undergo knee revision surgery in order to have the prosthesis removed or replaced.

What is 510(k) Premarket Notification?

Also known as the 510(k) Pre-Approval process, this is essentially a regulatory “shortcut” that allows medical device manufacturers and drug makers to bypass normal laboratory studies clinical trials, which are both time-consuming and costly. The original intention behind 510(k) Premarket Notification was to get medical devices to patients who could benefit in the shortest amount of time possible.

By demonstrating that a new device is “substantially equivalent” to an earlier model (known as a “predicate device”), testing requirements are waived. Unfortunately, this has resulted in many defective and dangerous products being implanted in patients’ bodies, such as knee replacements with faulty components.

How Many Zimmer Persona Tibial Plates Were Recalled?

FDA records indicate that nearly 12,000 Persona tibial plates have been voluntarily recalled. It should be noted that at present, only one component of the Zimmer Persona has been recalled – the tibial plate. This is the component that is inserted into the top of the shin bone.

How Do I Know if My Knee Replacement is Failing?

The most obvious symptom of prosthetic knee failure is severe knee pain, which worsens as time goes on. The patient will eventually lose range of motion and may not be able to walk or stand at all.

Long term, internal consequences may include permanent damage to blood vessels and nerves and bone injury.

Can The Manufacturer be Held Liable?

The failure of the Zimmer Persona knee replacement is not the first time this company’s products have been recalled. Zimmer has been targeted in numerous lawsuits over dozens of defective devices. An experienced knee replacement lawyer can advise you and help determine if you have a case.