Exactech, a medical device manufacturer, recently issued a total recall of all knee, hip, and ankle replacement implant systems manufactured after 2004.
The recall was launched after discovering that a polyethylene insert component was failing thanks to flawed packaging. Numerous Exactech knee implants became prematurely ineffective due to this packaging defect.
Unfortunately, this implant failure has and will force many to undergo corrective surgery needlessly. Knee surgery Patients who underwent revision surgery after an Exactech knee implant failed may be able to file a lawsuit.
So, on what premise can you file a lawsuit? Read on to learn everything about an Exactech recall lawsuit.
Exactech Lawsuit Updates
January 20, 2023 update
At a status conference next week, the judge overseeing the Exactech implant recall is anticipated to set a deadline for the litigants to present joint discovery and case management approaches.
On Tuesday, Judge Garaufis received a joint status report from the plaintiff’s and defendant’s attorneys documenting their work on specific administrative duties.
The report included the current discovery stage in the 86 consolidated Exactech recall lawsuits in Florida state court.
The report mentions that the claimants in the Florida lawsuits issued master discovery requests in early December.
It also states that Dr. Sharat Kusuma, the chief medical officer of Exactech, is scheduled to be deposed on February 16, 2023.
January 14, 2023 update
Hursey v. Exactech, Inc. et al. is an excellent illustration of recent litigation filed in the Exactech recall MDL in the Eastern District of New York.
The Truliant Knee System from Exactech, recalled in February 2022, is the implant device in this case.
Hursey underwent a knee replacement operation in July 2021 and got the Truliant implanted. However, by August 2022, the polyethylene insert material had already degraded, and a second operation was required.
Hursey’s primary basis of action in the lawsuit is manufacturing defect-based strict liability, although additional claims are made.
January 1, 2023
There are now 80 Exactech lawsuits proceeding in a Florida state court version of a class action MDL on top of the Exactech recall actions underway in the federal court MDL.
Exactech’s attorneys sent MDL Judge Garaufis a letter emphasizing the value of harmonizing the discovery processes in federal and state court cases.
This prompted Exactech to file a motion in the Florida proceedings requesting harmonization of federal and state discovery. Attorneys for the plaintiffs are challenging this motion.
December 27, 2022
During the inaugural status conference, Judge Garaufis agreed with the claimants that efforts should be made to catch up to the Exactech state MDL currently ongoing in Florida courts.
Judge Garaufis approved the motion to allow additional Exactech recall lawsuits to be filed straight in the MDL at the close of last week’s session. That makes it easy for everyone.
Additionally, he allowed several deadline extensions for the initial MDL housekeeping initiatives.
The judge formally appointed a group of 27 attorneys to fill various roles on the plaintiffs’ leadership committees for the case. There will be a steering committee for the plaintiffs, a liaison counsel, and an executive committee.
November 18, 2022
This week will see the first status meeting for the Exactech recalls MDL in federal court. A state court MDL is already in progress in the Florida judicial system.
With a first bellwether test trial scheduled for next year, the Florida state MDL is currently running well ahead of the federal MDL concerning timelines.
That has led several attorneys of both parties to ask the federal MDL court to speed up the proceedings to catch up.
Different plaintiffs’ attorneys have written letters to Judge Nicholas G. Garaufis requesting that he promptly authorize direct submissions in the federal MDL and appoint counsel to the plaintiffs’ leadership committee.
Recall of Exactech Knee and Ankle Replacement Implants
Exactech is a multinational manufacturer of medical equipment based in Gainsville, Florida. The company was founded in 1985 and focused on producing surgical implant systems used in joint replacement operations.
Exactech began a comprehensive countrywide recall of all knee, hip, and ankle replacement implants made after 2004 in August 2021.
The recall affects nearly 150,000 knee replacement devices in the U.S. total knee arthroplasty (TKA), a procedure to replace the knee, uses Exactech implant devices.
The TKA knee replacement procedure replaces damaged or deformed knee cartilage and treats severe arthritis-related pain.
The recalled products include:
System Release Date
OPTETRAK 1998
OPTETRAK LOGIC 2009
TRULIANT 2017
VANTAGE 2016
Exactech initiated the recall after discovering that the polyethylene insert element was oxidizing before use due to a flaw in the vacuum-seal packaging of their knee replacement systems.
TKAs contain a significant amount of polyethylene. Nevertheless, these inserts can’t be exposed to oxygen throughout packing and storage.
The early degradation of polyethylene inserts is caused by oxidization, a chemical process that occurs when polyethylene inserts are exposed to oxygen.
As a result, polyethylene inserts need to be produced, packaged, and stored with extreme caution. If they come into contact with oxygen, they will undergo what many of you reading this did.
What symptoms does a TKA experience as the insert ages? The patient experiences discomfort and a loss of function as their knees fail to function correctly in the knee replacement system.
What happens to the TKA when the insert degrades? The patient experiences knee pain and loss of function as the knee replacement system fails to function correctly.
Therefore, as time passes, the deteriorated polyethylene inserts create increased wear and friction. The Exactech knee replacement implants consequently prematurely fail. The result is frequently the need for early revision surgery.
Patients whose Exactech knee replacement system failed due to this manufacturing defect had severe knee pain and immobility.
When the knee replacement system eventually fails, the patient must have corrective revision surgery. Nobody who has undergone knee surgery desires a second procedure.
What Should Patients with Recalled Exactech Implants Do?
Doctors received a letter from Exactech informing them of the recall. The letter urges surgeons to immediately discontinue Exactech implants in all knee and ankle replacement procedures.
Additionally, it instructs hospitals and doctors to return any recalled medical devices already in their possession. This letter seemed rather honest in comparison to the rest of them. Exactech apologizes and acknowledges the mistake.
The recall notice advises patients who have had surgery and are already wearing an Exactech knee replacement implant to speak with their doctors.
Doctors are encouraged to keep track of every patient who has Exactech implants and to watch out for any indications of possible insert failure.
In addition, Exactech sent a draft letter that doctors would send to their patients detailing the reasons behind the Exactech recall. You may have already seen that letter.
If you have an Exactech hip, knee, or ankle replacement implant, you may need to watch out for indications of implant failure caused by a defective insert.
These include pain and swelling, instability in the knee or ankle, grinding in the joint, or difficulty bearing weight on the joint.
Practitioners are advised to take X-rays to assess the condition of the Exactech implant when they suspect a failed implant.
Exactech Knee Replacement Implant Lawsuits
Exactech and similar medical equipment manufacturers are required by law to ensure that their supplies are risk-free when utilized for the intended purpose and free of any dangerous defects.
The Exactech recall letter acknowledges that the company’s knee and ankle replacement implants were flawed.
Therefore, holding Exactech accountable for damages and injuries will be less challenging than an ordinary class action lawsuit.
Anyone who underwent revision surgery after 2004 and had an Exactech knee replacement implanted may be eligible to file a product liability claim if the implant later malfunctioned.
If their Exactech knee recall action is successful, the claimants would be entitled to compensation for their:
- Pain and suffering
- Medical costs related to their care and corrective revision surgery, and
- Any lost wages as a result of the hip, knee, or ankle implant failure.
If you have a strong case, you have a significantly better chance of winning an Exactech settlement than going to trial.
That’s because the proof of Exactech’s mistakes doesn’t just come from the plaintiff’s attorneys. The admissions that Exactech made following the recall make these lawsuits strong.
History of Problems with Exactech Knee Implants
The high failure rates of Exactech knee implants haven’t started today. Exactech has been getting 501(k) abbreviated FDA approval for its replacement devices to evade undergoing the entire FDA evaluation and approval process for a long time.
Exactech knew from the start that the failure rate of its OPTETRAK knee implant system was much higher than that of competing brands.
The FDA’s Manufacturer and User Facility Device Experience (MAUDE) reports noted that Exactech implants were failing at an excessively high incidence compared to other implants.
MAUDE reports reflect the increased rate of incidents of which Exactech had been aware for some years.
A search in MAUDE now returns all complaints concerning Exactech implant devices (at 500). As a result, not all Exactech complaints can be seen.
There are so many complaints concerning Exactech implant devices that a search maxes out at 500. That means you can’t even see all Exactech complaints.
Users with premature implant malfunctions filed product liability claims against Exactech in 2016 and 2017. Our partner attorneys have reviewed those lawsuits in the past.
The lawyers who brought those complaints couldn’t determine why Exactech knees malfunctioned.
They were watching the issue from a distance. However, these Exactech lawyers couldn’t comprehend why Exactech knees were malfunctioning completely.
These initial Exactech implant lawsuits recognized that the “finned” design element, which is exclusive to Exactech implants, was responsible for the high failure rate of these individual components.
These knee replacement suits claimed that Exactech failed to warn consumers of the risk but instead conducted a “silent” recall in which they gradually changed the finned design rather than recalling the products.
However, the Exactech recall exposed the particular oxygenation issue that contributed to the degradation of these components.
The company’s phase-out of the finned design didn’t reduce the overly high failure rate of Exactech’s implant systems.
They later used this information to look into potential weaknesses, which helped them find the faulty vacuum-seal packaging that sparked the voluntary recall.
Exactech Obtained Fast-Track FDA Approval
Between 1994 and 2017, Exactech consistently received FDA 501(k) approval for its Optetrak, Optetrak Logic, and Truliant complete knee replacement systems and components.
The FDA’s 501(k) clearance is known as “fast-track” approval since it doesn’t oblige the producer to attest to the product’s efficacy and safety.
This 510(k) approval form, commonly known as “premarket notification,” solely calls for the producer to demonstrate the device’s significant similarity to a pre-MDA baseline product.
The new product may then be “approved” by the FDA for sale in the U.S. The FDA granted 510(k) clearance for all component elements that make up the defendant’s Optetrak Device, or they were sold without 510(k) authorization or full FDA approval.
The biggest weakness in the 510(k) process is that the device manufacturer can demonstrate that the untested product is “substantially identical” to one available on the market for some time.
That means thorough testing is optional. These 510(k) products frequently arise in product liability claims because medical equipment that has not undergone thorough testing is more likely to have flaws.
Exactech Lawsuits Question Opterak Marketing
Exactech advertised the Optetrak as “first-in-class,” touting the superior quality of its components and long-term clinical success.
Exactech marketed the Optetrak system as having over three decades of clinical performance and demonstrable patient results due to an enhanced design that places less strain on the polyethylene insert components.
Optetrak has underperformed when measured against its rivals. For instance, the Optetrak has been classified as an implant with a higher-than-average risk of revision by the Australian Orthopaedic Association, a premier, worldwide recognized orthopedic implant registry.
The incidence of revision for an Optetrak-based total knee replacement substantially surpasses recognized revision rates set out by the worldwide community, according to the 2020 Australian National Joint Replacement Registry.
Exactech knew of the high rates of early implant malfunction with the Optetrak devices from the start. The Optetrak knee implants were malfunctioning at a considerably greater rate than Exactech reported in its marketing brochures as early as 2012, according to undisputed clinical documentation Exactech had.
Evidence of premature failure and correction related to the Optetrak replacement implants had already begun to build up In the FDA’s MAUDE database. These risk incident reports gave similar explanations for early Optetrak revision, indicating an implant defect.
Exactech Sales Reps Aware of Opterak Problems
Exactech follows the standard procedure: to have their certified sales representatives onsite during surgery to give the implant components to the surgeon.
This approach exempts the facility from the duty to keep all conceivable sizes and parts in store that could be needed during operations.
Exactech sales representatives were present throughout the first implant operation and subsequent revision surgeries.
Exactech sales representatives had witnessed countless Optetrak failures that were preventable. They noticed unequivocal proof of the plastic implants’ early degradation, which the surgeons frequently observed.
These sales representatives would usually take the component from the surgeon and bring it back to the business for examination and analysis.
It was the duty of Exactech’s engineering and medical departments to investigate and analyze the removed component when brought back (a process known as retrieval analysis).
They are also required to truthfully report their findings to the FDA and the surgeons after the Exactech sales representatives have reported their observations. They didn’t do this, unfortunately.
Exactech’s sales representatives informed the company of the problems. But despite mounting evidence that the Optetrak was predisposed to early failure, Exactech kept marketing and selling the implants without warning doctors, patients, or the FDA.
Exactech never updated the packaging, promotional materials, or product inserts despite knowing of the issues in 2021 to adequately and appropriately alert patients and physicians to the elevated risks of early Optetrak failure that go along with them.
The company didn’t even act by launching a safety recall of the Optetrak and other implant devices until August 2021.
Exactech May Have Intentionally Concealed Opterak Problems
Exactech published a pretty good “Dear Doctor” letter when making the recall announcement. So, is this a reputable business admitting to making a mistake and apologizing? Not exactly.
Exactech and its business officials knew the Optetrak knee implant technology was flawed, as shown by a wealth of evidence.
Without a doubt, Exactech was aware that the Optetrak implants had an unusually high early failure and complication rate and tended to wear out prematurely than other implants.
Yet, it took years for that to result in a recall.
Exactech May Have Hid Concerns Before Selling Company with Optertak and Other Implants
All evidence shows that Exactech knew of the Optetrak flaws around 2012 or 2014 at the latest. But by then, Exactech’s founders were likely considering selling the company to make some money.
A private equity firm named TPG Capital announced in 2017 that it was acquiring Exactech. TPG completed its acquisition of Exactech in February 2018.
Exactech became a privately owned business after TPG paid $49.25 per share to acquire all of the share capital of the company’s stock. A few years later, the company recalled its knee and ankle implants.
The recall would have devastated Exactech’s shares and perhaps resulted in several shareholder lawsuits if it had been initiated before the company went private.
Exactech May Have Quietly Replaced Some Defective Implants
Exactech recall lawsuits assert that the manufacturer was aware of early TKA system failures and secretly started changing the tibial trays in specific Optetrak devices.
The company did this under the radar and didn’t do it for everyone. Therefore, neither the public nor the medical community knew there was a problem.
The most significant settlement awards may go to plaintiffs who had Exactech implants between when Exactech seemed to know of the issue and the subsequent recall.
If this evidence is presented to a jury, the jurors won’t be impressed and, in some states, will award punitive damages.
Potential Settlement Payouts for an Exactech Knee Recall Lawsuit
There are no reported verdicts or settlements on Exactech implant lawsuits yet. Therefore, we can’t predict the potential settlement sum or jury award for an Exactech recall lawsuit.
But according to our partner attorneys, you may estimate the compensation amounts for the defective Exactech implant lawsuit by correlating them to those for comparable knee replacement settlements and knee-injury-related personal injury cases.
Let’s begin by estimating a relatively modest compensation amount. The typical compensation award for tort cases involving knee injuries is around $110,000.
However, the Exactech recall lawsuit settlement sums will probably be more. A jury will have a more negative outlook on your medical device manufacturer than the typical personal injury defendant for knee injuries.
Punitive damages will also be on the table. Therefore, at the very least, you double the anticipated settlement sums in these recall lawsuits. Using this logic, let’s estimate that Exactech settlement payouts will be $220,000.
We can also review past knee replacement cases to estimate average individual compensation amounts. Similar mass tort cases have been resolved, with the average settlement for individual cases being $200,000 in value.
Exactech’s liability is rather apparent. In its letter to doctors, the firm essentially indicts itself. Liability is highly evident, just as it was for knee replacement litigation many years ago.
Therefore, the calculation must take inflation into account. The best projection using this as a benchmark for settlement amounts in 2023 is $300,000 for Exactech recall lawsuits.
Example Exactech Logic Knee Implant Lawsuit
Burke v. Exactech Inc., 1:22-cv-020806 (S.D. NY) was among the first post-recall lawsuits filed in New York’s federal court on March 14, 2022.
James C. Burke, the claimant, got Exactech Optetrak Logic implants fitted in his left and right knees in 2013 and 2016, respectively.
Burke’s implant only worked for a brief period. The lawsuit alleges that he experienced discomfort, unsteady gait, and bone loss a few years after the operation.
Burke eventually had a lengthy correction procedure in 2019. He contacted an attorney to file a recall lawsuit against Exactech.
The product liability allegations in his lawsuit rely mainly on the company’s February 2022 announcement of the recall of all Exactech knee, hip, and ankle implant devices.
Burke’s Exactech recall lawsuit presents the recall attributed to the flawed packaging and early degradation of the plastic liner inserts as proof of a defective Optetrak implant.
He alleges that Exactech knew about these defective inserts but carelessly failed to warn physicians and patients.
Burke’s Exactech recall lawsuit alleges that the “accelerated polyethylene wear” in the Optetrak inserts was the primary cause of the premature failure of his knee implants after only six years.
Burke’s lawsuit made ten different charges. But strict liability based on a production defect is the central premise of tort liability in this lawsuit.
He is asking for punitive and compensatory damages to cover his medical bills and agony.
File Your Exactech Recall Lawsuit Today!
No patient should needlessly experience pain or harm due to a defective medical product.
You might be entitled to compensation if a recalled Exactech knee, hip, or ankle implant injured you or someone you know.
Legal Giant can help you get the best legal representation in your case. We partner with the best attorneys who will gather the evidence, file the Exactech recall lawsuit, represent you in court, and ensure you get the maximum compensation.
Contact us today for a free case evaluation.
