Does your joint replacement have a warranty?

Does your joint replacement have a warranty?

Should joint replacement manufactures provide a warranty for their products?  It seems pretty logical since most consumer products come with some sort of warranty these days.  Basic warranties are almost universally provided and the market for extended warranties is increasingly popular.

Take for instance my recent upgrade to the new iPhone 5s.  At the time of purchase, the AT&T store suggested their extended warranty above and beyond Apple’s provided warranty.  For a small amount of money, my phone is now protected from all kinds of disasters (for a limited time, of course).

Warranties are provided for most manufactured goods, so why not joint replacements?  Think about it.  Joint replacements are manufactured to extremely tight tolerances.  They are rigorously tested both in the lab and in humans.  Catastrophic failure of the components is rare.  From a purely manufacturing stand point, it would seem that joint replacement components would be an ideal product on which to provide a warranty.

As an orthopaedic surgeon, my patients typically ask me, “How long will my knee replacement last?”  This seems like a simple question on the surface, but is actually quite complicated to answer.  In the past, we used to say “about 10 to 15 years.”  However, that does not reflect the current state of materials and surgical techniques.  Current studies show that approximately 96% of knee replacements will still be functioning after 15 years.  However, these survivorship studies are based on older technology and the results may be even better than that now.  Ultimately, this longevity is pretty remarkable and it is reasonable to think that most modern knee replacements will last many decades.

However some replacements do not last this long and require a revision (second surgery to fix a problem).  The failure of a joint replacement can occur for many different reasons.  These include infection, trauma, loosening (non-infectious), wearing out, or poor implant positioning. These problems could be caused by the patient, the surgeon, the implant or may be unknown.

When revision surgery is necessary, it creates a very stressful time in a patient’s life.  These stresses include financial hardships, loss of time at work, and can be emotionally taxing on the entire family.  Additionally, this type of surgery may not have an excellent or even satisfactory result.

In the United States there is only one manufacturer providing a warranty on their joint replacement product. Biomet is now promising a “lifetime warranty” on their partial knee replacement.  This would seem to be a step in the right direction and I applaud Biomet for their forward thinking in this arena.  Is it possible that this could become the new standard from joint replacement manufactures?

As with every warranty, it is always important to read the disclaimer information next to the asterisks.  Let’s examine the good parts of this warranty.  If a covered Oxford partial knee replacement needs to be revised, Biomet will provide the components, for free, for a second partial replacement or provide the components for the conversion to a total (full) knee replacement.  According to my conversation with a Biomet representative, this warranty is applicable if a revision is needed for any reason, except for products that are past their expiration date at the time of implantation.

The potential problem however, may not have anything to do with the warranty itself; rather it is how this warranty would be provided.  Typically, when a consumer receives a warranty on a product this gives them a sense of protection from financial loss associated with a defect in the product.  However, that may not be the case here in this situation.

This warranty only covers the cost of the prosthesis itself.  It does not cover any hospital costs, co-pays or related expenses.  This means that if a revision is necessary, the patient may still have significant financially responsibilities for the surgery and related expenses.  According to the warranty, Biomet will provide the knee components for the revision surgery at no charge to the purchaser.  In most cases, the purchaser of this equipment (prosthesis) is not the patient; rather, the purchaser is the hospital/surgery center.

The hospital would essentially receive the implants for free, saving several thousands of dollars associated with the surgical procedure.  There would be no requirement for the hospital to then pass this cost savings onto the patient’s insurance company.  If the savings were somehow to be passed on to the insurance company, there is no requirement for the insurance company to pass this savings on to the patient.  Ultimately, this type of warranty could help to lower the overall cost of healthcare (for the health care industry), but may not provide significant direct help to the patient.

If this warranty were to be used, I would encourage any hospital/insurance company that would be benefiting from this warranty to make sure their patient is somehow provided that financial benefit.  I believe that future warranties on joint replacement components have the potential to provide real savings and security to the patient.  I hope that as more manufactures start to follow suit, they continue to find ways to implement these warranties to the benefit of our healthcare user, the patient.

Brian Hatten is an orthopedic surgeon and creator, My Knee Guide

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  • Thomas D Guastavino

    Unless the device has a clear cut defect, the Biomet warranty model has the potential to create as many problems as it solves. Patients are not likely to read and understand the “asterisks” so I can imagine an interaction going like this:
    Several years after an uncomplicated TJR a patient patient comes in with a loose prosthesis. There is no obvious cause. Needing a revision, the surgeon explains that yes the prosthesis itself is covered but not the surgery or subsequent treatment. Under the impression that the the procedure was “under warranty” the patient becomes angry that they have to pay anything. Try as that might the surgeon fails to convince the patient otherwise. You now have an angry patient and we all know what angry patients do.
    By the way, the answer I give when asked how long do the implants last I say to think of the implant like a pair of top quality running shoes. They are made well put the more you run on them then faster they are likely to wear out. This has worked well for me.

    • Deceased MD

      Hi Dr. G
      I was hoping you would find this and thanks for a most thorough answer. A warranty does sound kind of ludicrous. Probably a marketing ploy on the manfacturer’s part.

      But the question I also was thinking of, if you have a moment, was with the Johnson and Johnson hip replacement that was touted to be safe. The principal investigator apparently, hired by J and J, apparently manufactured false results in his study. Finally a surgeon in England complained about it, since many were finding there to be a device failure. Jand J denied it and kept selling them and surgeons not in the know, kept operating. Now an enormous number of lawsuits against J and J. I imagine you are well aware of this as an orthopod. Any thoughts? What concerned me when I read about it, was that as an MD you couldn’t believe the study since it was outright falsified. I fortunately don’t have pts with this problem, but it made me feel less sure of studies than ever.

      • Thomas D Guastavino

        I never used the device so I never followed closely the chain of events that led up to the ASR device being pulled from the market. I do know that there were limited clinical studies and that the device was approved under the “like products” doctrine of the FDA. Heres what I know:
        The “standard” hip replacement is the one in which there is a metal stem placed in the upper femur with a metal cup placed in the acetabulum. In between is a polyethylene plastic cup acting as the bearing surface where all the motion occurs. Years ago that plastic was the weak link and when hips failed is was commonly due to failure of the plastic. Ironically, the manufacturing process has improved so much that this is no longer the case but several years ago there were attempts made to eliminate the problem by having having different bearing surfaces not needing the plastic. Ceramic heads are one option that is being tried but they tend to be very expensive.
        The ASR hip was an example of what is known as a “metal on metal” implant in which there is no bearing surface and the hip moves smoothly because the metal surfaces were so highly polished. What seemed to happen is that the motion of these hips caused metallic ions and debris to wear odd causing localized reactions that led to the hip failing. It took a while for this to happen so longer term studies would have been needed to discover the problem. I don’t believe there was purposely falsification of then data.

  • Thomas D Guastavino

    The same way any other consumer deals with any defective product. You dont use it.

  • Caroline Burkat Hall

    I had a Biomet Oxford implant taken out and a new Biomet total knee implant put in almost 3 years ago (March 2). I wish Biomet had had this warranty now. The partial implant didn’t fail, my knee instead developed arthritis everywhere else in the knee. At the time of the original surgery, the arthritis was confined to the medial compartment. A year and a half later, I started getting pains in the rest of my knee. I would have had it revised then except that my other knee was already scheduled for its own TKR.

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