A Step Backwards
Robert expected his hip implant to last his lifetime--instead he needed revision surgery two years after the device was recalled. “We were vacationing in Phoenix from Edmonton when I had this blinding pain. I got off the stool I was sitting on, put one foot on the floor and that’s as far as I got,” Robert says. “My friends happened to have a walker so they helped me sit back down and we waited for the ambulance.” The hospital in Phoenix confirmed that Robert’s hip was fractured and put him on the waitlist for revision surgery but his insurance company arranged surgery in Robert’s home town as an operating room was available sooner. “Two days later I was medivacked back to Edmonton with my wife, four months early. So much for wintering in Phoenix.
“Oddly enough a few days before this happened, I was feeling some discomfort, which was unusual as I never had any problems with my hip replacement. Now that my surgeon told me about Exactech hip and knee implants I’m surprised it lasted so long,” adds Robert. “My new hip joint is healing but not as good as the initial implant. I’m sore all the time and can’t walk like I used to – I have to slow my pace and shorten the distance and that’s not boding well when I play golf.” Robert’s lawyer says he has a cause for action. “I want the manufacturer to take some responsibility because I may have some limitations down the road,” he says. “I would like some compensation, at least for medical expenses, pain and suffering. Recovery this time was twice as long as my first hip surgery. I also had to cancel another trip so there’s lost airfare, and more. I’m 73 years old and I’ve got lots of years ahead, but this is a step backwards.”
After reviewing court documents in patient lawsuits, a pending whistleblower lawsuit, and other government records, A KFF Health News report reveals that Exactech is being sued for failure to disclose to both patients, the medical community and federal regulators, evidence of product failures. And it has downplayed or concealed evidence for years. “In hundreds of instances, according to government records, the company took years to report adverse events to a federal database that tracks device failures.”
Exactech and the FDA
That federal database is MAUDE -- Manufacturer and User Facility Device Experience--a gigantic, searchable databank that warns the public of dangers linked to medical devices and drugs. The FDA states that The MAUDE database houses medical device reports submitted to the FDA by mandatory reporters, i.e., manufacturers, importers and device user facilities, and voluntary reporters such as health care professionals, patients and consumers. Manufacturers are required to report to MAUDE within 30 days when knowing their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm. According to court and government records, Exactech didn’t get the FDA’s memo.
Instead of 30 days, Exactech reported adverse events sometimes years later, or not at all. KFF Health News found about 400 examples in which Exactech reported adverse events to the MAUDE database two years or more after learning of them. And an Exactech representative revealed that the company didn’t advise to the FDA dozens of early revision complaints reported by orthopedic surgeons. Rather, Exactech shifted the blame of defects to surgeons and that it had no obligation to report poor outcomes due to surgeon mistakes, despite the FDA requiring manufacturers to also report any “user error”. Yet surgeons complained that the implants loosened prematurely, causing patients pain and limiting their ability to move around, according to court records.
Those surgeons likely weren’t on Exactech’s expense account. According to a government database called Open Payments, Exactech paid surgeon consultants who used the company's implants in the operating room or promoted them in advertising $23.2 million combined from the start of 2013 through the end of 2022. Again, KFF Health News wrote that, “In promoting the Optetrak in sales materials, Exactech touted "excellent results" achieved by orthopedic surgeon Raymond Robinson. Left unsaid: Exactech paid Robinson more than $900,000 in consulting fees and other payments from 2013 through 2022. In a court filing, Exactech denied any consultants ‘were compensated in exchange for product promotion.’ Robinson could not be reached for comment.”
READ MORE DEFECTIVE HIP IMPLANT LEGAL NEWS
Exactech Litigation Update
Lawyers representing over 300 injured patients in a Florida court are demanding 2,435 complaints to the company alleging deficiencies with Exactech knee products. In other pending lawsuits nationwide, patients claim that Exactech ignored evidence of chronic safety issues and put profit over people. ConsumerNotice reports that, as of October 2023, there were 842 lawsuits pending in New York multidistrict litigation. So far, there have been no trials or no trials or approved settlements in Exactech recall lawsuits.