Drug Recall Lawyer Blog
The surgical implant manufacturer Exactech recently announced a recall of all its Optetrak® implant systems used in total knee replacement surgeries since 2004. The recall came after the company discovered that a problem with the product packaging was causing the polyethylene insert component in the Optetrak implants to degrade not function properly. This defect is causing the Optetrak knee implant systems to prematurely fail which ultimately requires patients to undergo additional revision surgery.
Individuals who had the Optetrak system implanted and suffered premature failure due to this defect can file a product liability lawsuit against Exactech and potentially recover financial compensation for their pain and medical bills. Our firm is currently accepting Optetrak implant failure cases from patients who suffered a premature failure to their knee replacement implant and had to undergo revision surgery.
Opterak Exactech Recall Lawsuit – April 2023 Update
The pace of new Exactech lawsuits has been slow. The recall of Exactech knee, hip and ankle replacement implants covers an estimated 150,000 people. Doctors are notifying patients when they complain of new problems.
But people who already had a revision surgery have not heard about the recall and these lawsuits. Neither have victims who have symptoms but have not yet seen a doctor. Exactech is suggesting individual doctors send out recall notification letters to patients. But the company is not notifying patients.
Also this month, the judge who is in charge of the Exactech MDL has allowed all future lawsuits concerning Exactech implants to be filed directly in the MDL. This makes filing suit a bit easier.
How many Exactech lawsuits are there? The number of new Exactech implant recall lawsuits experienced a considerable increased as of April 19, 2023, as 111 new cases joined the Exactech class action lawsuit through filing or transfer within the last 30 days. This represents the most substantial monthly rise since litigation began, bringing the total of pending cases to 290. It’s likely that this marks the beginning of a trend that will persist for the rest of the year. In addition, over 80 Exactech cases are currently awaiting resolution in a Florida state court MDL.
Recall of Optetrak Knee Replacement Implants
Exactech is an international medical device manufacturer based in Gainesville, Florida. The company was originally founded in the 1980s by a group of orthopedic surgeons and it specializes in surgical implants for joint replacements. The Optetrak and Optetrak Logic are Exactech’s proprietary line of knee replacement implant systems.
Last year, Exactech commenced a global recall of all Optetrak system knee replacement implants manufactured after 2004. The recall impacts over 140,000 Optetrak implants used in knee replacement surgeries (referred to as total knee arthroplasty) in the U.S. Total knee replacement surgery is generally utilized to for the treatment of severe chronic pain caused by arthritis.
The Optetrak recall was initiated after Exactech realized that the vacuum-seal packaging used for its products since 2004 was defective. The packaging was not air tight which allowed the polyethylene insert component of the Optetrak system to oxidize and degrade before use. The degraded insert was not able to function properly triggering excessive wear and tear. This excessive stress from the defective insert eventually causes the Optetrak knee replacement system to fail prematurely.
Premature failure of the Optetrak knee replacement implant due to the defective insert causes significant pain and immobility in in the knee. Patients who suffer an early failure of their Optetrak knee implant eventually have to undergo additional corrective surgery to replace the defective implant.
What Should Patients with Recalled Optetrak Implants Do?
Exactech is issuing a letter about the Optetrak recall to all known patients and their doctors. The letter advises doctors to immediately stop using Optetrak implant systems in all knee replacement surgeries.
Patients who already have an Optetrak implant system in their knee are advised to consult with their doctor to determine the best course of action. Exactech is requesting doctors to keep an index of all their patients with Optetrak implants and carefully monitor them for signs of potential insert failure.
Symptoms that an Optetrak implant may have failed due to the defective polyethylene insert include pain and swelling, inability to bear weight on the joint, grinding in the joint, or immobility in the knee. Doctors should take X-rays when a failed implant is suspected so as to evaluate the status of the implant.
Optetrak Knee Implant Lawsuits
Like all manufacturers, Exactech has a legal obligation to ensure that their surgical implants are safe and free of any potentially harmful defects or flaws. The recall of all Optetrak implant systems is essentially an admission by Exactech that these implants contained a manufacturing defect, therefore, Exactech can be held liable for all resulting injuries and damages.
Any patient who had the Optetrak knee system surgically implanted during their knee surgery can pursue a product liability case against Exactech if the Optetrak implant failed and they needed corrective surgery to replace it. If a plaintiff brings a successful Optetrak knee implant lawsuit, they would be entitled to damages for (a) pain & suffering; (b) medical expenses related to the revision surgery or other medical treatment; and (c) any lost wages or income caused by the knee implant failure.
Prior Optetrak Litigation
The Optetrak knee replacement implant had an extensive history of litigation even before the recall due to high failure rates and other problems. The Optetrak was approved under the abbreviated 501(k) FDA clearance process, which means it was never subject to a full FDA review and approval. The 510(k) clearance process is a notification system for medical device manufacturers to inform the FDA at least 90 days before marketing a device claimed to be “substantially equivalent” to a device the FDA had approved for sale before 1976. This process does not require clinical testing and clearance for sale under the 510(k) process does not equate to FDA approval. That comes with risk, right?
Very soon after the implant were released, Exactech became aware of abnormally higher failure rates with the Optetrak implant system compared to other devices.
Reports on Optetrak knee implants in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) showed that the implants were failing at much higher rate than any other type of implant devices. There are currently so many complaints about Optetrak implants in MAUDE that a search of the database exceeds the display limit of 500. The adverse reports in MAUDE only reflected a percentage of the actual failures. Exactech was internally aware of countless other failures that were not reported in MAUDE.
Between 2015 and 2017, reports of the excessively high failure rates with the Optetrak implants sparked a number of product lawsuits against Exactech by patients who experienced premature implant failures. These previous Optetrak implant lawsuits alleged that the high failure rate was related to general design defects, including the unique “finned” design feature of the original Optetrak system.
Instead of warnings doctors and patients, Exactech responded to this by pursuing a “silent” recall in which they gradually phased out the finned design without announcing anything. When this change to the design of the Optetrak did nothing to decrease the alarmingly high failure rates, Exactech began to investigation other explanations. This is was eventually led them to discovery the problem with the defective vacuum-seal packing which was causing the polyethylene inserts to prematurely degrade and malfunction.
Sample Optetrak Lawsuit
Failure to Package Polyethylene Components
These defects include the failure to package the polyethylene components of the Optetrak Device in vacuum bags containing a secondary barrier layer that could prevent the components from undergoing increased oxidation and causing patients to experience accelerated polyethylene wear, component loosening, and/or other failure that caused serious complications including tissue damage, osteolysis, and other injuries.
Negligent Packaging
The defendants also used inferior grade or quality materials to package the Optetrak Device, and the device as manufactured differed from the defendants’ intended specifications. Additionally, the defendants failed to measure and test an adequate number of samples of the Optetrak Devices on an ongoing basis, take corrective actions to eliminate or minimize further failures of the device, and perform adequate quality control or other such testing on the polyethylene inserts used in the device to ensure they complied with required specifications.
Negligent Manufacturing
The lawsuit alleges that the defendants violated state and federal laws and regulations in the design, manufacture, and distribution of the Optetrak Device. The plaintiff claims that the defendants knew or reasonably should have known and been aware that the Optetrak Devices were defectively manufactured and that the manufacturing defects presented an unreasonable risk of harm to users and patients exposed to their danger, including the plaintiff, when used and operated for the purposes intended by the defendants.
The plaintiff also alleges that the manufacturing defects of the device presented an unreasonable risk of harm to users and patients exposed to their danger when they were used and operated in a manner that was foreseeable to the defendants.
The lawsuit further claims that the plaintiff could not have discovered the manufacturing defect and perceived its dangers or avoided injury by the exercise of reasonable care. The defendants are strictly liable for the defective manufacture of the Optetrak Device, the distribution, marketing, and/or sale of the defectively manufactured device, and the injuries sustained by the plaintiff.
Harm to the Plaintiff
As a direct, proximate, and legal consequence of the defective nature of the Optetrak Device, the plaintiff has suffered debilitating injuries and damages, including pain and discomfort, swelling, buckling, gait impairment, poor balance, component part loosening, soft tissue damage, bone loss, bone damage, and other injuries presently undiagnosed, which all require ongoing medical care.
The plaintiff also claims future damages, including but not limited to the cost of medical care, rehabilitation, home health care, loss of earning capacity, mental and emotional distress, and pain and suffering. Finally, the plaintiff seeks compensatory and punitive damages, as well as interest, costs of suit, attorneys’ fees, and all such other relief as the court may deem just and proper.
Potential Settlement Value of Optetrak Implant Lawsuits
We don’t have any reported settlements or verdicts for Optetrak knee implant lawsuits. Many of the previous Optetrak cases appeared to get resolved by settlement, but the terms were confidential so we can’t be certain what the likely value of these cases will be.
However, we think Optetrak implant lawsuits will have a settlement value comparable to tort cases involving moderate knee injuries. The average payout in personal injury cases involving knee injuries is $70,000 to $150,000 and this is probably what we can expect for the value of Optetrak product cases.
File Your Optetrak Knee Implant Lawsuit
If your Optetrak knee replacement implant failed and you had to undergo corrective surgery, contact us today to see if you have a case.