The Legal Examiner Affiliate Network The Legal Examiner The Legal Examiner The Legal Examiner search instagram avvo phone envelope checkmark mail-reply spinner error close The Legal Examiner The Legal Examiner The Legal Examiner

FDA Issues Exactech Recall Reminder

The Food and Drug Administration (FDA) has issued a reminder that a defective joint replacement device could cause complications for patients. In 2021, orthopedic implant company Exactech voluntarily recalled some joint replacements after discovering that the packaging wasn’t correctly sealed. Last year, the company expanded the recall to include more knee, hip, and ankle replacements. The FDA included hundreds of thousands of devices in these recalls. 

A defective implant presents a unique problem for healthcare providers because joint replacement devices can’t be removed without surgery. It’s a procedure with serious risks and can take months to recover fully. The FDA says in its reminder notice that people who aren’t experiencing negative symptoms don’t need surgery, but these patients are now at risk for an implant failing long before it should.

close up of lots of parts for transplantation of leg joints and tools for surgical operations on replacement of joints lie against a metal surface

Exactech Joint Replacements

Founded in 1985 by doctors, Exactech says that it aims to produce innovative implants to help surgeons and patients. The company was acquired in 2017 for $737 million and boasts that it has helped hundreds of thousands regain mobility. Almost a quarter of American adults have arthritis, which causes joint inflammation, making walking and completing daily tasks hard. Rheumatologists usually recommend less invasive treatments like medication and physical therapy before considering a patient for surgery. During joint replacement surgery, a surgeon removes and replaces the damaged joint with a prosthetic device. Most implants have an expected lifespan of 10 to 25 years. 

Exactech discovered that 80% of its implants manufactured since 2004 were packaged in defective vacuum-sealed bags. The bags lacked a barrier layer to prevent deterioration, exposing the devices to oxygen that can cause premature degradation. When the polyethylene liner of an implant oxidizes, it can wear down faster. Some signs that a hip, knee, or replacement is degrading include reduced mobility, increased joint pain, trouble bearing weight, and hearing a grinding or clicking noise. 

Exactech joint replacement failure puts patients at risk of serious health complications. Bacterial infections, joint dislocation, and severe pain can all result after a device fails. Revision surgery is usually recommended to remedy the problem but is riskier than a typical joint replacement procedure. The surgeon must remove the old implant, dead bone and tissue, and the cement that holds the implant together. The success rate for revision surgery is lower than a first-time replacement, and there’s an increased chance of bone fractures and dislocation. Most joint replacement patients won’t need follow-up surgery, but the risk is higher among Exactech patients.

Exactech Patients: What’s Next?

While Exactech reached out to patients after the announced recalls, some may still be unaware that they may be potentially affected. If you’ve received a joint replacement and want to know whether you’re affected by the recalls, it’s essential to contact your doctor to find out the type of implant you received, its lot number, and serial number. You can visit Exactech’s website to see if your device is included in the recalls. The company has created a process to submit out-of-pocket treatment costs for reimbursement, but many patients choose to sue. 

Even if the company does repay patients for medical expenses, its reimbursement process doesn’t account for non-economic damages like pain and suffering and reduced quality of life. Manufacturers have to ensure that their products are safe for the public, and the plaintiffs in Exactech lawsuits allege that the company didn’t exercise due diligence. Essentially, those affected by the defective devices say the company failed to warn consumers about the potential harm. A failure to warn lawsuit can be successful even if the manufacturer does know about the danger if a plaintiff can show that the company reasonably should have known about the risk. 

Exactech lawsuits have been consolidated into multidistrict litigation (MDL) to streamline the process, and more than 200 cases are currently moving through both state and federal court systems. If you have an Exactech implant, you should contact a lawyer to consider your legal options before filing a claim with the company directly. You could be eligible for more compensation than you realize, and an attorney can evaluate your potential case and help you decide the best way to move forward.