A Lifetime Guarantee on a Shoulder Implant? This Device Maker Is Offering It Through Geisinger

A group of U.K. researchers collaborated with researchers from the National Institutes of Health to answer a question: How long does a shoulder replacement last? They found that about 90% of shoulder replacements last for longer than 10 years.

One Swiss medical device company — Medacta — is hoping to improve that statistic. Through a collaboration with Pennsylvania health system Geisinger, Medacta is providing a lifetime guarantee for its shoulder implants. In mid November, the two organizations announced that a Geisinger orthopedics surgeon had became the world’s first to operate on a woman undergoing a reverse shoulder replacement using Medacta’s shoulder implant with that lifetime guarantee.

“Geisinger and Medacta will stand behind the full cost of care throughout the patient’s lifetime,” stated the Nov. 19 news release from the two organizations.

The collaboration between Medacta and Geisinger as it relates to shoulder surgery expands upon the lifetime guarantees that Medacta and Geisinger provide in hip, knee and spine surgeries through the latter’s ProvenCare. It is a value-based care program meant for patients covered under Geisinger’s own health plan.

In an interview, Matt Goudy, the managing director of Medacta in the U.S., explained that the systemwide chair of Geisinger’s Musculoskeletal Institute approached the company back in the day to explore this lifelong guarantee concept.

“All this work around outcome guarantees, it’s really the brainchild of Dr. Michael Suk. And apparently he had searched high and low for an implant manufacturer to partner on such a concept,” Goudy said. “Everyone else that he’d spoken to prior to us probably scoffed and thought he was crazy. I certainly did too but I didn’t say, ‘no.'”

The lifetime guarantee started with Medacta’s hips and knees, Goudy recalled, though it took a few years to figure out the details, primarily because what Suk wanted wasn’t just a simple implant guarantee: rather, it was an outcomes guarantee, he explained.

So, some common-sense caveats determine who may not be eligible to receive the implant and care with a lifetime guarantee — for instance, people who smoke or have uncontrolled diabetes. But Goudy was careful to reiterate that a patient’s implant eligibility is ultimately the surgeon’s decision.

“There’s no set criteria where the company would ever say, ‘No, no, no, surgeon, you’re wrong.’ Then we’re in that dangerous ground where we’re almost practicing medicine,” Goudy declared.

For Dr. Mark Pallis, the surgeon who performed the reverse shoulder replacement surgery with the first-ever lifetime guarantee, the decision was simple. The recipient was a healthy nurse anesthetist at Geisinger with a normal BMI and no comorbidities, so he spent no time agonizing over implant eligibility. Dr. Pallis noted that he has used shoulder implants from a Medacta competitor — Naples, Florida-based Arthrex, which he believes provides the “best combination of implant and service,” but was very struck by the amount of training Medacta provided.

“What I like about Medacta, to answer your question, is they are very focused on physician education and physician training. … When they approached me to consider their implants, they sent me to courses … before I did my very first one in a real patient,” he recalled. “And then I had an opportunity before my first arthroplasty to meet virtually with another surgeon who had done lots of them. And we discussed my preoperative planning ….”

He also found certain design elements in Medacta’s implants appealing.

“They have a little bit more interesting design where there are screws for example, that for the base plates on the reverse, they’re a combination of a cortical screw, which provides compression and locking screw, which provides support,” explained Dr. Pallis. “Most implant companies have either a cortical screw or a locking screw. This is a combination in one single screw, which is nice.”

But what Dr. Pallis finds really compelling is the European company’s NextAR surgical guidance platform, an augmented reality platform that provides preoperative, personalized 3D planning as well as data to the surgeon during surgery. The surgeon wearing the goggles can view the data over their operative field of vision. It also enables real-time instruments guidance and accurate implant positioning.

“What it does do is it helps me exactly match my preoperative plan to the patient. Arthrex for example, has a patient-specific guide that I’ll use to put the guide pin. Then everything else is up to me and the preoperative plan. Whereas with the NextAR, I have goggles or I can look on the screen and once I have the sensors calibrated, it gives me exact positioning of the guide pin, exact reaming depth, exact placement of the screws and the length based on my intraoperative plan. And I can change it based on what I’m seeing in the operating room using the CT scan. So in other words, by changing the angle of approach for my screws, for example, I can say, ‘Well gee, that looks like I’ll have better purchase if I put it here at 36 millimeters versus 34 millimeters,'” he explained. [Getting good purchase means that the surgeon has been able to affix the surgical implant to the bone in a stable and secure manner.]

Dr. Pallis is waiting for more data from more surgeries, but he believes that NextAR might end up making shoulder replacement surgeries much more accurate and in line with the preoperative plan. He said he is not aware of any other company that offers this kind of augmented reality service during surgery. He added that the lifetime guarantee that Medacta is offering might give the company a bit of a leg up compared to its competition.

“Medacta is relatively late to the shoulder arthroplasty game and maybe they’re trying to break in and be innovative, but I also think they stand by their products,” Dr. Pallis said.

Does it automatically follow that Medacta will begin to aggressively scale the lifelong guarantee in other medical centers and with more of its surgeons base? The short answer is no. Goudy explained that surgeons are carefully chosen based on their performance metrics and have to undergo a certification process.

“You have to be very, very selective on the surgeons that qualify and get certified for these programs,” Goudy said. “I think if you look at our size and scale currently in the marketplace, it allows us to be very selective. If you are a massive market share player and you start to offer a program like this, far more of your customer base is not going to qualify than would.”

In fact, even at Geisinger, not all surgeons will qualify to be able to perform surgeries with Medacta’s lifetime guarantees. And then, there has to be an alignment between health systems and Medacta too.

“There has to be an appetite for such risk on the part of the provider as well,” Goudy said. “But you mentioned value-based care, that is where everything’s heading. And this is something that we really believe differentiates us from the other implant manufacturers by stepping up and being willing to go at financial risk on the outcomes associated with the products that we offer the surgeons.”

Top photo: doomu, Getty Images