The medical device company Exactech recently issued an urgent recall for thousands of hip, knee and ankle implant systems due to defective components included in the device. The recall was issued as a result of defective packaging which could cause early degradation and lead to total failure. Individuals implanted with these devices face a considerably increased risk of joint replacement complications and failure, with an estimate of over 147,000 potentially defective devices implanted since 2004.
Exactech is a global medical device company founded in Gainesville, Florida in 1985. Since its inception the company has released a wide variety of surgical instruments and software, but has specialized in orthopedic implant devices needed for joint replacement surgery. The company has been involved in legal matters in the past – in 2017, a number of product liability lawsuits were filed addressing abnormally high failure rates in its Optetrak knee replacement implant. They’ve faced other lawsuits alleging improper consulting agreements with doctors and surgeons who noticed alarming defects in their implant systems (ModernHealthcare.com).
In August 2021, the FDA issued a sweeping nationwide recall of all knee and ankle joint replacement systems manufactured after 2004. The devices were recalled after it was revealed that the polyethylene plastic insert components included in all of their replacement systems were contained in defective packaging. This defective packaging allowed an excess of oxygen exposure to the components, and this oxidation has caused an increased degradation of materials over time.
Figure 1A shows radiographic imagery capturing the catastrophic results of polyethylene degradation in total hip arthroplasty. In this patient, such degradation created osteolysis, a progressive condition in which bone tissue softens and degenerates, which then necessitated the following three revision surgeries (Figures 1B, 1C, and 1D). Figure 2 shows a similar result in total knee arthroplasty; this degradation of materials can create catastrophic results in joint replacement implants, leading to total failure.
This defection has been confirmed in the Optetrak, Truliant, and Vantage product lines. Currently, the recalled replacement systems include:
Because of this defect, patients who have received an Exactech replacement are at risk for a number of painful side effects, which could potentially necessitate revision surgery. If your replacement is defective and failing, you may experience osteolysis (bone loss) with or without symptoms. Other symptoms to look out for include the following:
All medical device manufacturers – including Exactech – are obligated to ensure that the products they manufacture safe for implantation and will perform effectively and free of defect. By issuing a recall, Exactech admits that they distributed dangerous and dysfunctional devices, and therefore can and should be held accountable for the widespread harm they have knowingly caused.
Our attorneys have decades of experience in seeking justice for victims of defective joint replacements, having recovered hundreds of millions of dollars for people who have been injured, disabled, or have died due to faulty medical devices. The Defective Joints team at Wilentz has a national defective medical device practice with a reputation for obtaining maximum compensation for our clients, due to our broad expertise and many years of success.
Our team has won lawsuits for consumers against companies like Johnson & Johnson, Smith & Nephew, Zimmer Biomet, Stryker, and more. Currently, we are actively engaged in investigating and pursuing claims against Exactech. If you or a loved one has been implanted with an Exactech joint replacement system, contact our office as soon as possible to discuss your potential claim. Our team will work tirelessly to assist you and protect your rights.
If you have been implanted with an Exactech device, please be careful in discussing this issue with anyone other than your attorneys, as your rights may be impacted and/or waived. You Should not sign any paperwork until you confer with the legal counsel of your choice.
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Medical Device Watch is sponsored by Wilentz, Goldman & Spitzer, P.A. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.LEARN MORE