Exactech knee, ankle, and hip implants may fail prematurely due to polyethylene (plastic) inserts that were packaged improperly before implantation. Premature failure of these devices may lead to the need for corrective revision surgery.
The inserts were supposed to be packaged in vacuum bags containing a layer of ethylene vinyl alcohol (EVOH). This EVOH layer, which helps makes the bags more resistant to oxygen, was missing from the bags the inserts were packaged in.
The bags without the layer of EVOH may cause too much oxygen to reach the inserts before implantation, leading to oxidation of the inserts, which can cause the inserts to wear out prematurely or become damaged after implantation.
Reports from as early as 2012 in the Manufacturer and User Facility Device Experience (MAUDE) database noted that Exactech’s implants were failing prematurely. However, it wasn’t until August 2021 that Exactech began recalling devices containing defective polyethylene inserts.
California law allows victims of defective medical devices to obtain financial compensation for injuries caused by the devices when device manufacturers knew or should have known their devices were dangerous but failed to warn about it.
You may be eligible for financial compensation in an Exactech lawsuit if you or a loved one has suffered a failure of an Exactech knee, ankle, or hip implant. Our expert Exactech recall attorneys offer free consultations and don’t charge a fee unless and until we win your case.
What Exactech Devices Were Recalled?
Exactech has recalled components used in the following knee and ankle implants:
- OPTETRAK knee recall
- OPTETRAK Logic knee recall
- TRULIANT knee recall
- VANTAGE ankle recall
The following Exactech knee and ankle implant components have been recalled:
- OPTETRAK All-polyethylene CR Tibial Components
- OPTETRAK All-polyethylene PS Tibial Components
- OPTETRAK CR Tibial Inserts
- OPTETRAK CR Slope Tibial Inserts
- OPTETRAK PS Tibial Inserts
- OPTETRAK HI-FLEX PS Tibial Inserts
- OPTETRAK Logic CR Tibial Inserts
- OPTETRAK Logic CR Slope Tibial Inserts
- OPTETRAK Logic CRC Tibial Inserts
- OPTETRAK Logic PS Tibial Inserts
- OPTETRAK Logic PSC Tibial Inserts
- OPTETRAK Logic CC Tibial Inserts
- TRULIANT CR Tibial Inserts
- TRULIANT CR Slope Tibial Inserts
- TRULIANT CRC Tibial Inserts
- TRULIANT PS Tibial Inserts
- TRULIANT PSC Tibial Inserts
- VANTAGE Fixed-Bearing Liner Component
In addition, Exactech has recalled the Connexion GXL Acetabular Polyethylene Liners used in their Novation, MCS, and Acumatch hip implants.
In addition, the following products have been recalled:
- MCS Conventional UHMWPE NOVATION Conventional UHMWPE
- Exactech All Polyethylene Cemented Cup Acumatch Conventional UHMWPE
- Novation GXL
- MCS GXL
- Acumatch GXL
Compensation Available In An Exactech Ankle, Hip Or Knee Implant Lawsuit
If you suffered complications from a recalled Exactech ankle, hip or knee implant, Nadrich Accident Injury Lawyers can help you recover compensation for:
Medical Bills
You are probably already facing medical bills, possibly relating to a revision surgery. You may also need future treatment for your complications which will necessitate even more bills. We can help you recover compensation for all past and future medical expenses related to your complications.
Lost Wages
Your complications could have injured you so badly you were unable to work for a period of time. You might have also had to take time off work to have your complications treated. We can help you recover compensation for any wages you were unable to earn due to your complications.
Loss Of Earning Capacity
Your complications could have led to you being unable to ever work again, or unable to ever work in the same field again. We can help you recover compensation for any loss or reduction of earning capacity related to your complications.
Pain And Suffering
Your complications could have caused you physical pain and mental suffering. We can put an accurate value on this pain and suffering and make sure you’re fairly compensated for the pain and suffering caused by your complications.
Wrongful Death
You may have lost a loved one due to implant complications – you might have lost a loved one during a revision surgery. If this is the case, we can get you compensated for your grieving. We can also get you compensated for your loved one’s pain, suffering, medical bills, funeral costs and burial costs. We can also get you compensated for the loss of your loved one’s household services, income, love and companionship.
How Do I Know if I Have a Valid Exactech Lawsuit?
Exactech has admitted that most of their polyethylene inserts made since 2004 were packaged improperly in bags missing the layer of EVOH they were supposed to have, which let oxygen into the bags, causing the polyethylene inserts to degrade.
Degradation of the polyethylene inserts has led to device failure as well as injuries to surrounding tissue and bone. Many patients who have been affected by the inserts have needed invasive revision surgery, leading to lawsuits being filed all across the United States.
You have a limited amount of time to file a claim. If you’d like to know if you have a valid lawsuit against Exactech, call us today for a free consultation.
What Should I Do if My Exactech Implant Has Been Recalled?
If you have an Exactech hip, ankle or knee implant which has been affected by a recall, you should contact your doctor, especially if you’re experiencing:
- New or worsening pain
- Inability to bear weight
- Grinding or other noise
- Swelling
- Joint instability
You should contact your surgeon if you’re unsure whether you have one of the implants that have been recalled. The surgeon who did your hip, ankle or knee replacement surgery may contact you to make sure your implant is working properly and order X-rays if they suspect you have a failed implant.
Surgery is not recommended by Exactech for people who aren’t having pain or other problems like trouble walking. Exactech said patients and doctors should work together to make decisions about exchanging or removing devices. Doctors should explain the risks and benefits of every treatment option to patients.
On its website, Exactech explains the process for patients with defective implants to submit claims and receive financial compensation for implant-related expenses. However, our Exactech recall lawyers would like to let you know that any patients who file claims directly with Exactech might waive their rights to sue Exactech.
Patients who need revision surgery because of Exactech’s defective implants might be able to file a lawsuit against Exactech and seek financial compensation, including compensation for lost wages, medical bills, pain, suffering, and more.
Such a lawsuit may end up providing you with far more compensation than filing a claim directly with Exactech would. Because of this, you should speak to an Exactech knee, ankle, and hip recall attorney today before agreeing to a settlement with Exactech. You don’t want to forfeit your right to financial compensation in an Exactech implant lawsuit.
Grounds for an Exactech Lawsuit
The primary claim in an Exactech knee replacement lawsuit, Exactech ankle replacement lawsuit, or Exactech hip replacement lawsuit will be that Exactech knew or should have known its implants were dangerous but failed to warn about the danger. Because of this, Exactech recall lawsuits will seek to recover damages based on the cause of action known as strict liability: failure to warn.
Studies published in 2012 and 2016 found that Exatech’s OPTETRAK total knee systems performed poorly compared to competitors. The Australian Registry found that the OPTETRAK implants had a higher-than-expected revision rate.
By 2012, MAUDE reports regarding the recalled Exactech knee systems noted revision surgeries due to “loose tibial component,” “aseptic loosening,” “pain and visible loosening,” “polyethylene deformation,” “polyethylene worn,” and “pain, limited mobility, knee swelling, and sensitivity” due to “loose” joint.
Additional MAUDE reports in 2013 regarding the Exactech knee implant noted revision due to “tibial loosening,” “revision due to tibial loosening,” “during revision, the tibial component was found to be loose and easily removed,” “revision of knee component due to loosening,” and “revision due to pain and loosening.”
Additional MAUDE reports in 2014 regarding the Exactech knee device noted “revision due to tibial loosening,” “tibial loosening,” “revision of Optetrak knee components due to tibial loosening,” “revision due to pain and loosening,” “revision of Optetrak knee components due to aseptic loosening,” “revision of knee components due to tibial loosening,” and “revision of Optetrak knee components reportedly due [to] aseptic loosening.”
At some point before September 26, 2013, Exactech had been informed that its Connexion GXL liners tended to wear excessively in patients, necessitating revision surgeries to remove Novation hip systems.
Despite all of this, Exactech failed to warn doctors and patients of these risks, or recall their devices, until 2021.
Proving Negligence in an Exactech Lawsuit
In addition, an Exactech lawsuit will seek to recover damages based on the cause of action known as negligence, or failure to be reasonably careful to prevent harm.
An Exactech recall lawyer will argue that Exactech was negligent by:
- Failing to adequately test their knee, hip and ankle replacements, including the oxygen resistance of their implants’ components
- Failing to test enough sample devices regularly
- Failing to take the necessary steps to clearly identify ankle, hip and knee implant failure modes and suggest ways to prevent, avoid and/or monitor failures
- Failing to identify the significance of testing resulting in failure of their implants
- Failing to take corrective actions to minimize or eliminate failures of their implants
- Failing to adequately explain specifications for packaging the components of their implants
- Failing to adequately perform quality control before their products were distributed
- Failing to pay attention to reports, including reports from their own sales representatives, noting that polyethylene debris and osteolysis were apparent during revision surgeries
- Failing to implement investigations and corrective action in a timely manner to understand why device failures were occurring, while continuing to sell the devices knowing they would be implanted in thousands of patients
California law also allows for plaintiffs to recover damages for injuries caused by medical devices that are defectively designed or manufactured. An Exactech lawsuit will seek damages based on the causes of action of strict liability: manufacturing defect and strict liability: design defect.
Exactech Implant Failure Side Effects
The recalled Exactech implants can cause many different side effects, such as:
- Popping, grinding, clicking, or other noises
- Production of debris
- Dislocations
- Accelerated wear
- Inability to bear weight
- Component fatigue
- Joint instability
- Bone loss
- New or worsening pain
- Fractured components
- Swelling
- Cracked components
These are serious complications that may require revision surgery to correct.
Revision surgeries carry risks. For example, revision surgeries on knees can cause:
- Knee stiffness
- Reduced range of motion
- Poor wound healing
- Wound infection
- Bone fracture
- Blood clots
- Pulmonary embolism
- Heart attack
- Stroke
- Nerve damage
- Blood vessel damage
- Death
Exactech Knee Replacement Surgery Components Were “Fast-Tracked” By FDA
Exactech got 510(k) FDA clearance on a regular basis for its Truliant, Optetrak and Optetrak Logic knee implant components and systems from 1994 through 2017.
510(k) FDA clearances are known as “fast-track” approvals since they don’t require manufacturers to prove their products are effective and safe. The 510(k) path, also known as “premarket notification,” only necessitates that manufacturers explain that their devices are substantially equivalent to a device which has already been approved by the FDA.
The FDA might subsequently “clear” new devices to be sold in America. Every component part belonging to the Optetrak device was cleared under the FDA’s 510(k) process or marketed before receiving full FDA approval or 510(k) clearance.
The 510(k) process creates a loophole. This loophole is that device makers can give proof that devices that aren’t tested thoroughly are “substantially equivalent” to devices which have been sold for year. This means that full product testing isn’t required.
Dangerous medical device lawyers like those with Nadrich Accident Injury Lawyers frequently get involved in lawsuits involving products which go through the 510(k) process because the devices haven’t been tested thoroughly and are therefore likely to contain defects.
How Much Is My Exactech Lawsuit Worth?
In personal injury claims, it is common for a lawyer to look at past verdicts and settlements to tell clients how much their cases may be worth. The reason for this is that the values of past cases are a good way to gauge a case type’s general value.
Regardless, we treat clients independently and base how we treat our clients on their specific individual circumstances. Factors that impact a client’s case value include how severe their injuries are, what complications they suffered and more.
While verdicts or settlements in Exactech lawsuits haven’t been reported, recent hip replacement trials have seen awards of around $150,000 to $300,000. Knee implant cases typically have lower values than hip implant cases, but hard rules regarding this don’t exist.
Every defective device case and every individual case is different. The amount of compensation you may qualify for will end up depending upon your case’s specific facts. A past settlement is not a guarantee of a future award, but Nadrich Accident Injury Lawyers works hard to recover for our clients the largest possible settlements in their cases.
Exactech Knew Its Implants Had Problems
It is suggested by reports that Exactech knew about defects in their Optetrak knee systems even before TPG Capital acquired the company in 2018.
Exactech delayed the recall until it went private, and by doing so it might have looked to avoid a negative impact upon the value of its stocks as well as possible lawsuits by shareholders.
It’s alleged they quietly replaced certain defective implants while not publicly disclosing it. This further compounds concerns relating to accountability and transparency.
It is alleged by court records that sales representatives for Exactech witnessed surgeries and many cases of Optetrak devices prematurely failing.
Sales reps and surgeons both saw evidence that plastic inserts prematurely degraded.
Exactech sales representatives had a duty to report findings like these to the medical and engineering departments of the company. Despite this, the sales reps didn’t initiate the needed investigations or tell surgeons, the FDA or patients about the high failure rate of the implant.
This lack of transparency and action raises serious concerns about ethics and device manufacturers’ responsibility to make sure that patient safety is prioritized.
How Much Does an Exactech Recall Lawyer Cost?
Lawsuits against medical device manufacturers are known as products liability lawsuits. Most products liability attorneys, like us, represent clients on a contingency fee basis.
When you hire a lawyer on a contingency fee basis, the only fee you will ever be charged is a percentage of any recovery your lawyer obtains for you. You will not be charged this fee until and unless a financial recovery is obtained. Thus, if your lawyer doesn’t win your case, you owe your lawyer nothing.
Because of this, hiring an Exactech knee, ankle, and hip recall lawyer will not cost you a single penny out of your own pocket.
How Long Do I Have to File an Exactech Recall Lawsuit?
There is a deadline by which you must file an Exactech recall lawsuit. This deadline is known as a statute of limitations.
If you’ve been injured by a defective product like an Exactech knee, ankle, or hip implant, you have two years from the date you knew or should have known the product injured you to file a lawsuit in California. Failure to file a lawsuit within this time period can forever bar you from obtaining financial compensation for your injuries in court.
Do I Need an Exactech Recall Lawyer?
You need an Exactech recall attorney if you have suffered a device failure after having an Exactech knee, ankle, or hip implantation. The reason why is you will never receive all of the money you are entitled to under the law from Exactech if you don’t have a lawyer.
Your financial well-being is not Exactech’s priority. Their priority is their own profit margin. Therefore, they have no interest in paying you every penny you’re entitled to for your injuries.
Exactech knows that if you’ve suffered an implant failure, you’re probably facing tons of huge medical bills and you may be unable to work to pay those bills off. They know you’re probably desperate for money right now.
Thus, if you don’t have an Exactech knee, ankle, and hip recall lawyer, they’re going to quickly offer you a settlement that doesn’t come close to paying you all the money you’re legally entitled to, hoping you accept the settlement out of desperation.
Contact Our Product Liability Lawyers Today
The only way you’re going to get Exactech to pay you what you deserve for your injuries is to sue them. However, big medical companies like Exactech can afford expensive corporate lawyers who you can’t beat in court without strong, experienced products liability lawyers of your own like the ones at Nadrich Accident Injury Lawyers.
We’ve been handling product liability cases since 1990 and have recovered hundreds of millions of dollars for our clients in that time. Our lawyers can:
- Determine your eligibility to file a lawsuit during a free consultation
- Gather the evidence necessary to build a strong case for you
- File an Exactech lawsuit within California’s statute of limitations
- Pursue financial compensation for you in the form of a settlement or court verdict
Call us today or contact us online for a free consultation to see if you qualify for a lawsuit against Exactech. Our seasoned, expert attorneys can help you recover the largest possible recovery for your injuries.
Exactech Lawsuit Updates as of November 2023
August 21, 2024 Update
The judge overseeing the Exactech MDL approved an update to the pretrial schedule which the parties proposed. The update delays the beginning of the first two trials by several weeks in order to allow for more time for discovery.
A bit more time has been called for in order to prepare these claims to be tried before juries than originally provided. The start of the first trial has been pushed back from June 2025 to July 2025. The second trial, which was expected to start in August 2025, is now expected to begin in September 2025.
An order issued previously had set the dates for the first two trials for June and August 2025. However, this schedule was questioned after an Exactech recall happened in April 2024. This recall affected components used by plaintiffs in the bellwether trials.
On August 16, defendants and plaintiffs sent a letter to the judge which jointly proposed an update to the pretrial schedule in order to resolve any issues resulting from the new recall. The proposed schedule was approved by the judge.
August 12, 2024 Update
The judge presiding over the Exactech MDL agreed on a joint request regarding changing early test trials’ order. The trials are set to start in June 2025 and lawyers who are involved in other claims will closely watch them as they will help in determining how juries might respond to testimony and evidence which will get repeated during litigation.
The schedule changes got proposed as a response to an Exactech recall which was announced in April of 2024 which impacted some knee components which are at issue regarding two of the first bellwether trials. The schedule shuffling will give parties more time in order to complete discovery and won’t delay the first trial dates’ beginning.
Over 1,600 lawsuits have been filed regarding issues with defective knee, ankle and hip components which were first removed from the market in 2022 because of faulty vacuum-sealed bags.
The lawsuits claim the faulty bags allowed components to be exposed to oxygen before being placed in bodies, causing the components to degrade as well as prematurely fail, sometimes leading to a need for component removal surgery.
June 3, 2024 Update
Starting dates have been announced for the third and fourth bellwether trials in the Exactech MDL. The bellwether trials are part of an early series of test trials which are intended to gauge how juries might respond to certain testimony and evidence which will end up being repeated through over 1,200 claims brought over allegations that early device failure risk was increased by defective packaging.
The claims allege that vacuum-sealed bags which were “out-of-specification” allowed oxygen to reach artificial joints which were implanted in people, increasing the risk that the devices degrade and fail prematurely, necessitating surgery to remove and replace the devices.
Last month it was announced that the initial two bellwether trials will start in June and August 2025. On May 22, it was announced the third and fourth bellwether cases will begin in October 2025 and then January 2026.
In other news, 42 cases were added to the Exactech MDL in May, bringing the total number of cases to over 1,500.
May 6, 2024 Update
61 cases were added to the Exactech multidistrict litigation in April, bringing the total number of pending cases to 1,462.
April 30, 2024 Update
Trial dates have been set by the MDL judge. The first bellwether trial, involving Gayle Tarloff, will begin in June 2025. The second bellwether trial, involving Geraldine Larson, will begin in August 2025. The third bellwether trial, involving Dana Kessler Kramer, will begin in 2025 on a date to be determined.
For the fourth trial, parties will confer and agree upon a pick from plaintiffs’ lawyers by May 3.
The Tarloff case involves a New York woman who received an Optetrak Logic implant in 2016. The woman claims that she needed a revision surgery seven years later due to weakness, discomfort, stiffness and pain.
While it is frustrating that these trial dates are over one year away, we expect and hope that most of the lawsuits in the MDL will end up being settled prior to the Tarloff trial.
April 16, 2024 Update
The private meeting which the defendants had requested of the judge overseeing the Exactech MDL last month has been denied by the judge.
The request for the meeting had included asking for deadlines to be pushed back, which the plaintiffs pushed back against. The judge seemingly agreed with the plaintiffs’ objections to pushing back deadlines.
April 4, 2024 Update
147 cases have been added to the Exactech MDL in March, bringing the total number of cases pending to 1,401.
March 31, 2024 Update
Lawyers for Exactech are requesting a private meeting to be held with the judge overseeing the Exactech recall MDL, asking the court to give priority to global settlement negotiations instead of efforts regarding the preparation of claims for trials.
Exactech’s lawyers noted that the cost of the litigation has been substantial for Exactech as well as the plaintiffs, encouraging the court to discuss possible global litigation mediation before both parties incur more expenses in litigation.
March 23, 2024 Update
The FDA sent Exactech a warning letter regarding repeated issues with joint replacement implants’ packaging which led to numerous massive recalls as well as hundreds of lawsuits alleging device failures.
The letter indicates Exactech did not establish the proper procedures in order to prevent and correct packaging issues.
The FDA noted that packaging errors have caused devices to degrade on shelves, leading to:
- Joint subluxation
- Instability
- Subsidence
- Range of motion loss
- Pain
- Migration
- Total joint dislocation
Exactech is facing over 1,100 lawsuits alleging its joint implants prematurely failed due to manufacturing defects.
March 17, 2024 Update
A court has ruled that plaintiffs have failed in proving that private equity owner TPG Inc. sufficiently controlled Exactech in order to be held liable for any injuries. While TPG has influence over the business strategy of Exactech, the court did not find any evidence that they had complete control.
Product recall delays and insurance coverage delays were also deemed part and parcel of typical corporate operations.
Claims against TPG have thus been dismissed by the court.
This is probably not a big deal, but it would have been nice for plaintiffs to have an additional big pocket for contributions towards settlements.
March 9, 2024 Update
February saw 75 new cases added to the Exactech MDL, bringing the total number of pending cases to 1,244.
February 19, 2024 Update
79 new Exactech cases were added to the MDL in January, bring the total number of cases which are pending in the MDL to 1,169.
January 31, 2024 Update
The judge overseeing the Exactech knee, ankle and hip MDL has called for 12 lawsuits regarding knee replacements to be selected as bellwether trials, which will be tried in mid-2025. The lawsuits will involve complications with Exactech’s Truliant, Logic and Optetrak knee implants. Eight of the cases will be randomly selected, and the plaintiffs and defendants will each pick two more cases.
Exactech is facing over 1,100 lawsuits in federal court alleging that manufacturing defects led to joint implants failing prematurely.
December 1, 2023 Update
In October, the multidistrict litigation ordered that the company Exactech needs to produce around 35,000 documents since it was discovered that the documents were withheld inappropriately during discovery. The company already produced the documents, but in October Exactech filed a motion which asked the judge to essentially rescind the finding that the documents were withheld inappropriately. This is because lawyers for Exactech are complaining about plaintiff lawyers using the finding in state court. Exactech also complained in the filed motion regarding how producing the documents will cost around $38,000. The company likely spent up to 20 times as much in attorney fees disputing the documents being discoverable. The company is now spending yet more money filing this motion to reconsider.
November 1, 2023 Update
A video status conference regarding a class action lawsuit over the Exactech devices is now scheduled for 12-20-23. Some plaintiffs would prefer this litigation be moving more quickly.
184 cases were added to the MDL in the past month. There are now 842 cases pending. The total in June was only 391. The MDL has grown a lot.
Exactech MDL parties submitted to the judge a joint status report before a status conference. 984 cases are pending in the MDL according to the report. 811 of the cases involve knee implants, 164 involve hip implants, and 9 involve ankle implants. 327 more cases are pending in state courts in Florida, consisting of 233 knee cases and 90 hip cases.
Exactech plaintiffs’ lead counsel sent the court a letter in September which explained that a major dispute regarding discovery may be developing. The letter claims that Exactech refuses to produce documents which were requested during discovery. This includes documents which relate to prior litigation regarding Exactech, as well as documents which involve action that European regulators took involving Exactech implants. The defense team for Exactech now contends the documents aren’t relevant to current litigation, even though documents like these are extremely typical of documents produced in MDLs regarding mass torts.
October 1, 2023 Update
Exactech is facing a class action MDL. They are also facing a False Claims Act lawsuit which alleges Exactech committed fraud against the federal government when they sold defective knee implants to VA, Medicaid and Medicare. In this case, a judge ruled recently that the government probably would have denied payment to the company if they knew the implants had a high failure rate. The ruling is possibly significant regarding the plaintiffs making the argument in class action lawsuits.
All parties are looking for relif from the quickly moving bellwether trial and scheduling order. A joint brief filed by Exactech lawyers included a hearing transcription where a defense lawyer is talking about Exactech being a small company and how scheduling orders should consider this. This is puzzling, since Exactech’s market cap is estimated to between $4 billion and $6 billion.
The Exactech MDL has built momentum. 658 cases are now pending in the MDL – 267 new cases were moved into the MDL through the summer. The MDL’s size essentially doubled since Memorial Day.
September 1, 2023 Update
The Exactech litigation was the busiest MDL for a mass tort in America in July. Most MDLs saw record low case volumes filed in July, but the Exactech MDL almost doubled in size in July. 567 cases are now pending in the MDL. Only 136 cases were pending only two months ago. Florida state courts have another 272 cases pending.
822 claims are pending in the federal Exactech implant MDL. 665 of the cases are knee implant lawsuits. There are 146 hip implant lawsuits and 10 ankle implant lawsuits.
Exactech’s primary American office is in Florida, so victims are allowed to sue in Florida state courts. There are 272 lawsuits ongoing in state court, including 191 knee lawsuits, 77 hip lawsuits and 4 ankle lawsuits. 14 cases were filed in Illinois. 23 more claims were filed in other state courts.
In July, parties in the Exactech MDL submitted a plan for a proposed bellwether trial. There are also 80 Exactech lawsuits which are proceeding in Florida state court.
The bellwether plan which was proposed would look to coordinate federal and state MDLs by calling for bellwether trials in federal court focusing on cases which involve Exactech knee devices.
The Florida MDL would see bellwether trials held in cases which involve hip implants. The bellwether trials in the federal MDL would end up being selected from 24 knee implant lawsuits.
