The One-Year Anniversary of the Zimmer Persona Recall

Washington, DCOne of the most troubling aspects of the almost one-year-old Zimmer Persona Recall is the fact that Zimmer is the largest manufacturer and marketer of knee implants on the planet. And yet, such market penetration and expertise appears to have had little impact in the prevention of failures, which have resulted, for many, in Zimmer Persona knee pain.

There are numerous ironies. Zimmer - like other manufacturers of medical devices - is keenly aware of not only the burgeoning baby boomer sector and boomers' evolution from middle age into their retirement years, but also the fact that retirees of today are much more active and physically engaged than previous generations. They run marathons, they ski, they spend the day hiking. For them, a knee implant needs to be able to keep up with their ever-increasing level of physical engagement.

And yet, time and again, implant components designed for such an active lifestyle fail, and fail early - leaving recipients and plaintiffs involved in many a Zimmer Persona lawsuit facing not only pain and loss of mobility, but revision surgery and the resulting negative impact to their livelihood.

Busy people often have trouble setting aside the time needed for a surgical procedure and the resulting convalescence. Having to repeat such a procedure within mere months is a hardship that can negatively impact a job or career, employment income, and overall enjoyment of life.

The Zimmer Persona knee system is a complex design intended to personalize an implant to more uniquely fit within an individual’s bone structure. Various components are involved - from implant components to cutting tools and guides - and all designed to provide a more permanent and longer-lasting implant able to withstand the rigors of an active lifestyle. And it’s important to note that the Zimmer Persona Knee system has not been recalled, but rather a certain component: the Zimmer Persona Trabecular Metal Tibial Plate.

The component was found to have a tendency to loosen and create radiolucent lines, described as large gaps between implant components or between components and bone. Osteolysis can result from joint fluid, tissue or minute debris shed from the implant and lodging within the radiolucent line, or gap. Beyond the obvious pain and discomfort such a failure could cause, a loose implant would be an impediment to the simple art of walking. A senior heading to the ski hill with a loose implant, on the other hand, could experience dire consequences.

On February 16, 2015 - one year ago - Zimmer sent an urgent recall notice to the medical community. The recall was voluntary but nonetheless had the full support of the US Food and Drug Administration (FDA), which a month later formally issued a Class II recall of the Zimmer Persona Trabecular Metal Tibial Plate.

That first, initial communiqué to doctors, surgeons and hospitals issued on February 16 of last year pulled no punches: “All affected product are to be located and quarantined immediately,” the voluntary recall notice said, in part.

A month later, on March 12, 2015, the FDA issued its Class II recall of the Zimmer Persona Trabecular Metal Tibial Plate. “Zimmer Inc. is initiating a voluntary recall of Persona Trabecular Metal Tibial following an increase in complaints of radiolucent lines and loosening,” the text of the FDA’s recall announcement said. “All sizes and lots of the affected devices are being removed from distribution.”

That number totaled 11,658 devices, but it’s unclear whether that number was limited to tibial plates still on the shelf or included those already implanted into patients.

Hip and knee replacements are historically designed to last upwards of 15 years under normal use. Next-generation designs were intended to, at the very least, maintain that projected lifespan, but also make allowances for a more active lifestyle. Due to a loophole in FDA regulations known as the 510(k) Clearance, medical devices that are substantively similar to devices already on the market and performing well can skip the expensive and years-long clinical trial process, and instead go straight to market.

With the aging of the American population, more and more medical devices are entering the market under an FDA 510(k) Clearance.

Little wonder so many active seniors facing revision surgery are filing a Zimmer Persona Metal Plate lawsuit.