Implanted hips and knees don’t last forever. Surgeons try to schedule them in such a way that patients who get implants won’t need another, but there is no guarantee. For example, patients in their 60s are often advised to hold out for a few years so they won’t need a second hip or knee replacement in their 80s. A rule of thumb is that an implanted hip or knee should be good for at least 15 to 20 years, and possibly longer. A study in The Lancet found that knee implants were still good after 10 years in 96% of patients, and still working after 20 years in 90% of patients. Another study found more than 80% of knee replacements last 25 years or more.
Having to replace a hip or knee implant is debilitating, requiring recovery as well as rehabilitation with physical therapy. In addition to the cost, it’s also inconvenient and painful. What if you discovered the knee replacement that you worked so hard to heal from was failing prematurely? You would feel sad to say the least. What if you found out that the company that manufactured the implant knew their appliances were failing prematurely and didn’t tell anyone, including your doctor who recommended it based on assurances the product would last longer than the industry average? Your mood would probably turn from sad to mad. That is what happened to thousands of people whose had Exactech knee replacements in the past 20 years. This is from an investigation by Kaiser Health News:
Irby is one of more than 1,100 patients suing Exactech after it began recalling artificial knees, hips, and ankles, starting in August 2021. A letter Exactech sent to surgeons blamed a packaging defect dating back as far as 2004 for possibly causing the plastic in a knee component to wear out prematurely in about 140,000 implants. Many patients argue in hundreds of lawsuits that they have suffered through, or could soon face, challenging and risky operations to replace defective implants that failed.
According to a surgeon who installed more than 350 of the company’s knee implants, some of his patients began experiencing problems in as little as “two to three years.” The surgeon discussed this with the company founder during an encounter at a hospital around 2006 or 2007. During that discussion the head of the company that made the implants admitted they knew there was a problem and were addressing it. Yet the problem didn’t go away, and it took another 15 years before the company issued a recall. A recall at a medical device company isn’t like when your car has a recall to fix some small item. We’re talking about something implanted in place of your knee or hip.
One surgeon noted that 25 of the implants he had installed failed within four years. One failed and needed to be replaced in nine months. A whistleblower, formerly an executive at the company, said the product should have been recalled at least a decade earlier:
Exactech’s corporate confidence belies years of warnings and doubts about the durability of the Optetrak, according to whistleblowers — one whistleblower called it an “open secret” inside the company. Notably, there were concerns about the fragility of a finned tibial tray, one of the four pieces of the knee replacement that fits into the shin bone, according to the whistleblower lawsuit.
Medical device companies are required to track problems with their products in a complaint file. Indeed, there must be a formal procedure for recording and tracking complaints. Adverse event files also must be forwarded to the U.S. Food and Drug Administration (FDA), which places the information in a database available to the public and health officials. Medical device manufacturers are also required to investigate complaints and product failures and take corrective action. Reporting is supposed to occur within 30 days, but in some 400 instances it took the company years to report adverse events to the FDA. The company then blamed their product’s poor performance on surgeons, saying they had cemented the devices wrong or failed to adequately cement the implant to patients’ leg bones. The firm further claimed they had no responsibility to report failures due to the surgeons’ mistakes. Actually, they do. Furthermore, if a device is experiencing excessive problems due to surgeons’ errors that too requires an investigation and corrective action.
The entire article is worth reading: Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail.