Defective Machinery: Why do so few medical implants come with warranties?

Car companies compete on originality.

Movie studios compete on thrills.

What does it say about the medical device industry that a company has been able to compete on the fact that most device replacements come without a warranty?

Biomet, a maker of knee replacement products, proudly proclaims:

THE INDUSTRY'S ONLY LIFETIME KNEE IMPLANT REPLACEMENT WARRANTY† IN THE U.S.

Biomet advertises using a picture of a granny smith apple that has been partially peeled. It says:

Say this apple represents your knee. With total knee replacement, the entire surface has to be removed. But with the Oxford® Partial Knee from Biomet, you can keep up to 75% of your healthy knee – for a more rapid recovery with less pain and more natural motion.* Biomet also gives you the only Lifetime Knee Implant Replacement Warranty† in the U.S. Now that’s appealing.

I’ll write a bit about those “†”s later, but first let’s look at the knee replacement landscape.

See Also: Should Hip and Knee Replacements Come With Warranties?

Most of the other knee replacement companies are based in Warsaw, IN, just like Biomet. But none of them offers full replacement warranties. In fact, they don’t offer warranties at all.

Here’s what I found when I went hunting around the websites of the major knee replacement makers for any warranties related to knee replacement parts.

Zimmer

No Results found for: warranty

DePuy

Six results. None of them pertaining to knee replacements. But, interestingly, DePuy does provide warranties on a wide range of other products.

Smith & Nephew (based in London)

Sorry, no results found.

Contrast these slim pickings with a search on Swingline, maker of laminators, shredders, and staplers. The company has warranties for nearly everything that it makes, as far as I can tell. So you can get your stapler replaced if it breaks, but not your mechanical knee. Unless, of course, you buy that “appealing” knee from Biomet.

And about that Biomet knee. The “†” leads to quite a bit of fine print. Here’s what it says:

As more fully set forth herein, a limited Lifetime warranty, for the life of the patient, for the one time free replacement of the Product, or a component thereof, manufactured or distributed by BIOMET only. The free replacement of Product is limited to no more than one complete replacement of the Product. In the event, however, that a component of the Product (e.g., bearing) needs to be replaced only, such replacement(s) shall not be counted towards the limitation. If eligible, BIOMET'S replacement extends to a free replacement of the Product or component only and such free replacement does not extend to any guide, products, instruments, systems, devices, surgical or professional costs/fees or any services.

When you compare this to the stapler warranty, Biomet comes out quite well in one key regard: longevity. Swingline only guarantees that stapler for one year. Biomet is saying they’ll replace it at any point for the rest of your life. But Biomet, like Swingline, won’t pay for anything but the device itself.

This is why Consumers Union’s Safe Patient Project and other groups have cried foul over the warranty. This summer, the project’s manager Lisa McGiffert wrote the CEO of Biomet, Jeffrey R. Binder, saying:

Patients who must replace a flawed device endure many expenses. The warranty should cover full replacement costs of implants that fail, including those that break, crack, cease to function as intended or emit toxins into the body. A good warranty should clearly explain the process for its activation, clarifying and streamlining the process for a patient to pursue revision surgery and hopefully repair the hip or knee quickly.

Binder should get some credit. He’s out there with a lifetime warranty on a knee replacement product in a field where the norm is no warranty at all. That’s certainly a step in the right direction, no pun intended.

There may be a great rationale for not providing patients with warranties, but I have yet to see it. Can you point me in the right direction? Write askantidote [at] gmail.com or via Twitter @wheisel.

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