Why Are Medical Devices Failing?

Washington, DCIt’s been almost a year since the Zimmer Persona Recall and - specifically - the voluntary Class II recall of the Zimmer Persona Trabecular Metal Tibial Plate. The latter is a specific component of the Zimmer Persona system, and has led many a disgruntled and negatively impacted patient to file a Zimmer Persona lawsuit.

There has been a rash, in recent years, of medical device recalls (or their inherent components) due in part, according to pundits, to the 510(k) clearance maintained by the US Food and Drug Administration (FDA), a regulatory tool designed to fast-track promising devices to market - putting them in the hands of medical professionals sooner, and allowing patients to derive more immediate benefit without having to wait for years until results from prolonged clinical trials become available.

The Zimmer Persona Knee system was approved through such a 510(k) clearance predicated against devices already on the market. In fact, there are two such clearances posted on the official FDA website and both dating back to 2012 - which suggests that the devices in question were on the market less than three years before the Zimmer Persona Recall.

One component of the Persona system, identified as 21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metallpolymer semi-constrained cemented, was submitted for approval March 16, 2012. A few months later, components identified as 21 CFR § 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis and 21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented were approved under a 510(k) clearance December 5, 2012 following an application made in September of that year. The previous application appeared to have been reviewed and approved even more quickly - within a couple of weeks.

That was in 2012. Less than three years later, following a parade of adverse event reports suggesting failures including observance of radiolucent lines and loosening, the wheels were put into motion toward the removal of the failing Zimmer Persona Trabecular Metal Tibial Plate from the market.

In fact, the new year of 2015 wasn’t even a full month old when, on January 23, the Zimmer Persona Trabecular Metal Tibial Plate was pulled from the market by Zimmer. Less than three weeks later, on February 16 of that year, the FDA forwarded a notice of Urgent Medical Device Recall to surgeons and hospitals.

Less than a month after that, on March 12 of that year, the FDA officially dubbed the Zimmer Persona Recall as a Class II recall.

Zimmer, as manufacturers are required to do, provided assurances of successful tests, checks and balances that are part of compliance protocols associated with the 510(k) clearance. But a full-on clinical trial was never a part of the process - and never is, given that the product up for approval is predicated against other devices going as far back as 1995, in the case of one of the Zimmer 510(k) clearance applications.

And yet, 21 CFR § 888.3565 - Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis and 21 CFR § 888.3560 - Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented were predicated against devices brought to the market in 2002, 2007 and 2012 - the latter, the Persona Personalized Knee System (KI 13369, cleared March 27, 2012), approved through 510(k) less than nine months before.

Zimmer Persona patients experiencing Zimmer Persona Knee pain and having been subjected to revision surgery often file a Zimmer Persona lawsuit over the failed device, and the resulting impact on lifestyle, income generation, and other life and job factors.