Zimmer Persona Lawsuit: The Hell behind the Headlines

Warsaw, INWith baby boomers continuing to advance toward retirement and move through their twilight years, medical device manufacturers are racing at lightning speed to bring new products to the demographic segment and capture as much market share over their competitors as possible. In so doing, there have been failures that unfortunately affect not clinical trial participants, but well-meaning members of the general public who undergo a knee replacement and expect it to work. When it doesn’t, revision surgery is often required and is often followed by a lawsuit, such as those stemming from the Zimmer Persona Recall.

The Persona line features a series of advanced components designed to better reflect differences in body types related to gender and ethnicity, make it easier for the surgeon to install, and allow for a wider range of motion and advanced movement for a sector that is remaining increasingly active as they age.

And while the Zimmer Persona system is still on the market, one aspect of the Zimmer Persona was recalled last March: the Zimmer Persona Trabecular Metal Tibial Plate. At the time of the voluntary Class II Zimmer Persona recall of the component, the US Food and Drug Administration (FDA) noted “an increase in complaints of radiolucent lines and loosening.” Translated, far too many patients were experiencing Zimmer Persona Knee pain after the recalled component appeared to have failed soon after installation of the medical device.

At the time of the recall, the FDA noted there were about 11,700 of the units out there, affected by the recall.

It cannot be assumed that all 11,700 allegedly defective Trabecular Metal Tibial Plates are actually in patients. Some would have been on the shelf, in the supply rooms of hospitals, ready for use. However, given the pace at which total knee replacements are undertaken, a good number of those units - and perhaps even the majority - would have found their way into a patient’s leg via the operating theater.

This is why the Zimmer Persona lawsuit is so important. Even with advancements in modern medicine and surgical techniques, a knee replacement is sufficiently invasive that a good chunk of healing time is required, along with therapy and other rehabilitative processes the patient has to go through in order to ensure all healing is complete, muscle tone is restored and the knee operational. It can take several weeks, with a patient off work either completely or partially in order to allow for convalescence, physiotherapy appointments, and so on. In some cases, if a patient is still actively working, there may be a drop or a complete loss of income while the rehabilitation takes place.

Most patients will agree that such inconvenience is well worth the promise of a fully-functioning knee, without pain, for upwards of 15 years or more - the prescribed life of an artificial knee.

However, when a component fails, such as the Zimmer Persona Recall (of the Trabecular Metal Tibial Plate), revision surgery is often needed. Not only is a patient made to go through all of that again, but revision surgery is often more complex than the initial procedure, opening the door for increased complication.

Meanwhile a patient is made to go through the entire process of surgery, convalescence and rehabilitation just a few years, or even mere months following the initial procedure.

Such hardships are not reflected in a simple headline relating to a Zimmer Persona Recall. Unlike an automotive recall, that involves the simple swapping out of a part that might inconvenience the owner for an hour or two, a medical device recall can be devastating for the patient, for the family, and for all whose lives and associations hinge on the health and well-being of the patient.

Prior to the introduction of the FDA 510(k) Clearance, medical devices were rigorously tested in clinical trials that could take years. This meant promising products took far longer to reach the market, but as most problems were encountered and ironed out in the testing phase, the devices behaved well and in most cases reached the successful end of their prescribed life span with few exceptions.

Today, the opposite appears to be true. Such is the reason for a Zimmer Persona Metal Plate lawsuit.