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 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.
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 knee, ankle, or hip 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
- Joint instability
You should contact your surgeon if you’re unsure whether you have one of the implants that have been recalled. Your surgeon 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 lawsuit, Exactech ankle lawsuit, or Exactech hip lawsuit will be that Exactech knew or should have known its implants were dangerous but failed to warn about the danger. Because of this, an Exactech lawsuit 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 OPTETRAK 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 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 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, ankle, and hip implants, including the oxygen resistance of their implants’ components
- Failing to test enough sample devices regularly
- Failing to take the necessary steps to clearly identify 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
- Accelerated wear
- Inability to bear weight
- Component fatigue
- Joint instability
- Bone loss
- New or worsening pain
- Fractured components
- 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
- Nerve damage
- Blood vessel damage
How Much Does an Exactech Recall Lawyer Cost?
Lawsuits against medical device manufacturers are known as products liability lawsuits. Most products liability attorneys, like Nadrich & Cohen, 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 Nadrich & Cohen.
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.