Consumers Union’s Safe Patient Project is urging manufacturers of hip and knee devices to warranty their products. Most hip and knee implants perform well but sometimes they fail and have to be replaced because of product defects. Manufacturers should be willing to stand by their products with a warranty covering these defects and should establish clear actions for consumers to take if their implants fail. A warranty should cover the full cost of replacing the product, including your labor costs. We are asking surgeons to join us in this effort.

Q: Why should hip and knee implants be warranted?
A: Unlike most expensive products on the market today – cars, computers, major appliances – the vast majority of knee and hip implants are not warranted by their manufacturers. In fact, most patients get little to no written information prior to surgery about how long the device inside their body will last, or even its maker or model number. Compounding the problem is that most devices are exempted from safety testing before being put on the market and there is no national registry that tracks who has which implant in case of failure.

When an implant fails, the patient often has no idea what company made the device inside them, or how to get it fixed. Worse, most failures will require revision surgery, which entails chipping out the old device and replacing it with another – a costly surgery that patients, or their insurance or Medicare are on the hook for. Manufacturers often promote how long their products will last, but don’t back that up with a warranty – if they did, it would improve the safety and effectiveness of hip and knee implants.

Q: What kinds of problems would the warranty cover?
A: The warranty should cover full replacement costs when implants fail due to product defects, including those that break, crack, or cease to function as intended or emit toxins into the body. It would not cover failures due to hospital-acquired infections or medical errors. A good warranty should clearly explain the process for its activation, clarifying and streamlining the process for a patient to pursue revision surgery and repair the hip or knee quickly.

Q: What should a warranty cover?
A: We are asking device makers to offer a warranty that meets the following requirements:
• Specifies how long they intend to stand by their product.
• Covers the full replacement costs of the failed device, including surgeon and hospital costs, and related patient out-of-pocket costs for the revision.
• Gives the consumer the option to replace the failed device with another manufacturer’s product if the implant has been recalled by the FDA or the company, is the subject of FDA warnings, is under investigation by the FDA, or if the product is no longer being sold by the company.
• Establishes a clear system for patients to use, including a toll-free number and a registration number to track the claims process.
• Provides the patient with full information concerning a warranty claim denial and a process to allow the patient to appeal the decision.
• Does not limit or eliminate patients’ right to sue if they use the warranty.
• Does not disqualify patients across the board if they have specific diseases or illnesses that are unrelated to the device failure.
• Does not disqualify patients for normal activities, including falls.
• Does not disqualify patients due to information that is not routinely available to them, such as information that is on the device packaging or placed into their medical records.

Q: Won’t warranties stifle innovation?
A: Most products in the U.S. come with a warranty and it doesn’t stifle innovation – just look at the smartphone industry. Warranties could actually fuel innovation by providing more routine and timely feedback to companies and surgeons when patients seek to use them. That could lead to quicker fixes to product defects.

Q: Is there a history of these implants failing?
A: Yes. A review of medical device recalls over the past decade reveals that all major hip and knee implant manufacturers have recalled a product, or line of products, for defects. In the last ten years the six top selling hip and knee implant companies collectively issued 1,334 recalls.

Consumer Union reviewed complaints from the last 10 years concerning hip and knee devices in the FDA’s Medwatch database, where patients, physicians and others can register problems with medical devices. We found that common complaints include difference in leg length, continued joint pain, instability and limited range of motion, nerve damage, devices that did not adhere to the bone and tissue, and reaction to the materials that make up the device (for instance, patients with debilitating reactions to metal toxicity from all-metal hip implants).

Q: Aren’t hip and knee implant failures rare? Is this really a big problem?
A: Most hip and knee implants do not fail and people receiving them generally are happy with the results. But some of them fail. According to the American Academy of Orthopaedic Surgeons, approximately 10% of hip and knee implants fail, and some of those are due to product defects.

As the population ages and adults in their 40s and 50s want to play longer and harder, the popularity of hip and knee implant surgery is skyrocketing, putting many more people at risk. In 2012 there were nearly 1.2 million of these surgeries in the United States. That number is expected to quadruple by 2030, and more than half of those patients will be under the age of 65.

Right now, revision surgery makes up 18 percent of hip replacements, and 8 percent of knee replacements. Patients with hip and knee revisions are more likely to undergo additional revisions as compared to those with those who have had only one replacement.

Companies are marketing hip and knee replacements to active and younger people who will want to avoid the possibility of multiple revision surgeries. As surgeons, you want to assure your patients that these joints will last a long time, but your practice can also benefit from being able to assure them that the companies back their products with a warranty period that protects against product failures.

Q; Do any companies warranty their hip and knee implants now?
A: Currently, the only warranty in the U.S. market is for Biomet’s Oxford Partial Knee. Biomet offers a lifetime warranty, which is limited to one full replacement. It comes with a disclaimer of any liability outside of what is included in the warranty, such as pain and suffering, medical expenses and lost earnings. Consumers Union thinks Biomet’s warranty should cover the medical expenses required to replace its knee, just as “labor costs” are typically included in other warranties.

For more information go to http://lil.ms/i7f or contact safepatient@consumersunion.org