The New Normal in Medical Device Approval Requires Patient Diligence

May 18, 2016, 8:00AM. By Gordon Gibb

Washington, DCGiven today’s medical device environment, including the tendency for manufacturers to rush products to market through the 510(k) Clearance regulatory loophole made available by the US Food and Drug Administration (FDA), it’s incumbent on the patient to be proactive in managing or at the very least remaining conversant with regard to his or her own cases. The Zimmer Persona Recall is one such example.

It was on March 12, 2015 - a little over a year ago - that the FDA released its official recall notice with regard to the Zimmer Persona Trabecular Metal Tibial Plate, the problematic component of the Persona personal knee system that was proving so troublesome for patients experiencing Zimmer Persona Knee pain.

All lots and sizes, numbering 11,658, were subject to the recall, which extended to the continental United States, Canada and throughout the world to South Africa and the United Arab Emirates.

The Zimmer Persona Recall of March 2015 by the FDA was the regulator’s official response and acknowledgment of Zimmer’s own voluntary recall of the 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 official FDA notice began. “All sizes and lots of the affected devices are being removed from distribution. Urgent Medical Device Recall notices were issued to affected distributors, hospitals, and surgeons on 2/16/2015 via mail. Customers are asked to review the notification and ensure affected personnel are aware of the contents. All affected product are to be located and quarantined immediately.”

Locating the devices stocked on hospital shelves waiting for insertion is somewhat easier than locating medical devices already implanted in patients. When you do, what then? Patients already having experienced failure of the component would be looking at revision surgery, and presumably looking into a Zimmer Persona lawsuit as a result. But what of patients who have yet to experience issues?

Recalling a failed medical device is not as straightforward as recalling a shoddy part in an automobile, whereby the owner can bring it into the shop where the suspect part would be swiftly swapped out for a new one. Human beings aren’t that service-ready. No surgeon is going to undertake revision surgery for a component that has yet to fail and poses no risk to the patient until it does, if ever.

And therein lay the rub: While the Zimmer Persona Trabecular Metal Tibial plate has a failure rate sufficient to persuade Zimmer and the FDA to undertake a complete and total recall of the troubled component, there are those who continue to have a good experience with the device, and may well be fine. Provided the Zimmer Persona patient is not derailed by constant worry that his or her knee might fail at any time, life can continue to be enjoyed without distraction, waiting for the other shoe (or knee) to drop.

That’s assuming the patient has a clue as to what has gone into his or her knee in the first place. Many will not. Others might have a faint memory of something during the initial consultation with the surgeon, but failed to document the conversation, and the make and model of the prosthetic knee for future reference.

That’s more important than ever, given the environment in which a majority of medical devices are approved.

The 510(k) Clearance is an opportunity for the manufacturer to fast-track its product to market with full FDA blessing without the need, expense or expansive time required for a full clinical trial. Provided the new or updated device is substantially similar to that which is already on the market and performing well, it is deemed worthy of dispensing with the complex and costly clinical trial process involving a representative group of volunteers, and instead is launched into the market to a largely unsuspecting public.

The advantage to the 510(k) Clearance is that it allows promising devices onto the market more rapidly, benefiting patients with little delay. The downside, however, is the possibility that products with an unseen and untested Achilles’ heel, rears up to bite an unsuspecting patient constituency.

Any patient actually aware of the component he or she received and experiencing Zimmer Persona knee pain may not be aware of the fact that his or her prosthetic knee system was brought to market under an FDA 510(k) Clearance…

But there it is, on the official FDA recall document of March 12, 2015: 510(k) # K121771.

In fact, perusing the official FDA 510(k) database reveals there are two 510(k) numbers attached to the Zimmer Persona Knee system - both dated 2012. The Zimmer 510(k) attached to the Zimmer Persona Recall was dated November 2012. That means the device associated with that clearance was only on the market for a little over two years, before it was recalled.

Then, two months AFTER the Zimmer Persona Recall, Zimmer was approved for another device and awarded a 510(k) Clearance for the Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer.

The date on that document is May 20, 2015 - one year ago, and issued nine weeks after the Zimmer Persona Recall.

All the more reason for patients, in this age of the 510(k) Clearance fast track, to be diligent: research the device proposed for you, know its strengths and weaknesses, make an educated decision, then verify and document exactly what you got.

That may come in handy down the road should you ever have the need to file a Zimmer Persona lawsuit. You can’t just blindly trust the system any longer, as the system makes it too easy for mistakes to happen. It’s the new normal.