Exactech lawsuits allege that individuals who received certain replacement implants from Exactech Inc. need further operations to undo the harm the defective devices may have caused.
The product liability lawyers at our law firm are researching and taking claims involving Exatech revision surgery.
If you have questions regarding your rights in the lawsuit, causes of action, or other questions, contact our attorneys at (702) 940-1234 to discuss your options.
Why Are People Filing Exactech Replacement Lawsuits?
Exactech lawsuits are being brought by individuals seeking compensation for losses sustained due to potentially flawed Exactech hip, knee, and ankle implants. The Plaintiffs assert, among other things, that Exactech knew the devices were defective and was negligent in selling them.
Counts against Exactech include:
- Breach of warranty
- Failure to warn
- Strict product liability
According to the April 2022 Urgent Medical Device Correction letter from Exactech, at least 143,484 implanted possibly flawed inserts in the United States may have been implanted. Numerous thousand Americans with Exactech ankle or knee replacements may have been at risk of early failure due to these devices.
What Do We Know About The Exactech Lawsuits?
Numerous Exactech products have been recalled, including ankle, knee, and hip replacements.
Exactech Knee and Ankle UHMWPE Inserts
Exactech notified hospitals, medical professionals, and knee and ankle surgeons of an urgent medical device correction on February 7, 2022. According to the letter, the company has increased its recall, initially scheduled for August 31, 2021, to cover “all ankle and knee arthroplasty polyethylene inserts packaged within non-conforming bags despite the label or shelf life.”
Exactech claims that vacuum bags that were not compliant were used for package inserts produced after 2004. The bags do not have a secondary ethylene vinyl alcohol (EVOH) barrier layer, despite being oxygen resistant, and EVOH is used to increase a device’s resistance to oxygen.
Compared to inserts packaged with the second barrier layer, the ultra-high molecular weight polyethylene (UHMWPE) insert experiences higher oxidation due to oxygen diffusing due to this decreased resistance.
The UHMWPE may degrade as a result of the additional oxygen, leading to the following:
- Bone loss
- The disintegration of bone cells (lysis)
- Accelerated wear debris production
- Component fatigue fracture/cracking
- Requires corrective revision surgery
The Food and Drug Administration (FDA) declared the recall Class II.
Exactech’s notice states that non-compliant packaging has been used in approximately 147,732 inserts implanted throughout the United States since 2004. The recall includes all non-conforming Exactech Ankle and Knee UHMWPE implants, regardless of how long they have been on the market.
Surgeons have urged the avoidance of implanting non-conforming replacements.
Exactech has made the list of the devices, descriptions, product codes, and serial numbers that are affected available online. Devices from a variety of Exactech knee and ankle systems have been recalled:
- Optetrak: 60,926 implants since 2004
- Optetrak Logic: 60,518 implants since 2004
- Truliant Knee Replacement: 24,727 implants since 2004
- Vantage Ankle Implants: 1,561 implants since 2004
Connexion GXL Hip Replacement
Exactech has also had similar issues regarding its hip replacement devices, in addition to these recalls of knee and ankle devices.
Surgeons, hospitals, and other healthcare professionals received an urgent communication from the corporation on June 28, 2021. According to the letter, several Connexion GXL patients suffered wear that resulted in acetabular osteolysis and proximal femoral.
Roughly 90,000 hip replacements using Exactech Connexion GLX Liners were subject to this recall.
Patients With Ankle, Knee, And Hip Replacements May Not Be Aware Of The Recall
Exactech has yet to individually contact individuals who got their recalled ankle, knee, or hip replacements. Instead, the company gave surgeons a sample letter to contact any patients likely to have been harmed by the faulty medical equipment.
A patient would not be aware that their replacements would cause harm or injury if they moved, their surgeon retired, or they failed to notify them.
Patients with an ankle, knee, or hip replacement can use Exactech’s online tool to check if their replacement was officially recalled. Your medical records contain the device’s serial number, which you must have to enter.
Exactech Side Effects & Injuries
Exactech’s ankle, knee, or hip replacements may prematurely deteriorate, resulting in several medical problems.
Synovitis is a term used to describe a medical disorder in which the synovial membrane lining the body’s joints becomes inflamed. Pain is brought on by the swelling, especially when the joint is moved. Long-term synovitis can lead to the deterioration of the afflicted joint.
Hard lumps or nodules, swelling, and joint discomfort or tenderness are all indicators of synovitis.
Osteolysis of the Bone
In the pathological process of osteolysis, osteoclasts actively destroy bone tissue, releasing minerals and causing calcium to move from bone tissue to the blood. This syndrome frequently appears close to artificial joint replacements or prostheses, such as total hip and knee replacements.
The body strives to remove plastic or metal wear fragments from the synthetic ball and socket joint using replacement devices. The endeavor sets off an immunological response that causes living bone tissue to resorb. Osteolysis caused by the replacement devices can ultimately result in shattered bones and/or implant loosening in an implant recipient.
Within a year of having a knee, ankle, or hip replacement implanted, this process may start, and it progresses typically and calls for replacing the prosthesis during a revision operation.
Implant Revision Using a Replacement Insert
Although the United States doesn’t have a registry for joint replacement, Exactech’s knee implants had a high failure rate according to a high-level analysis of registry data from New Zealand, Australia, and the United Kingdom:
- In Australia, the knee revision rate is 10%. Out of 3,684 Exactech Optetrak knee replacements, the polyethylene component caused 374 revisions. The most frequent combination of total knee replacements, Optetrak-PS/Optetrak, increased the cause of polyethylene wear during revisions by three to seven.
- U.K.: The cruciate-retaining femoral component of the Exactech Optetrak TKR System demonstrated statistically significant elevated cumulative revision rates.
- New Zealand: 63 complete knee revision surgeries among 661 direct Optetrak total knee replacements, with a twofold spike in revision rate over all other primary total knee replacements.
Exactech encourages surgeons to have an open mind when treating patients who have undergone knee or ankle replacements and complain about the following symptoms:
- worsening or new pain
- inability to support the weight
- Grinding or another noise
- Instability in ankle or knee
Surgeons should thoroughly monitor affected patients for the following.
- Potential wear
- Associated failure modes
Exactech suggests that a surgeon takes X-rays if they believe the joint replacement device has failed. If the Exactech ankle and knee devices are working and the patient isn’t in pain, the manufacturer cautions against removing them prematurely.
Exactech advises doctors to consider revision surgery if early polyethylene wear is identified and following their medical expertise.
Exactech Lawsuit Settlements
It would help if you were informed that Broadspire, a settlement adjusting business, has been hired by Exactech to handle claims compensation for people who participate in this procedure. The website for Exactech provides information on how to submit a claim.
However, please be aware that Exactech claims it will only pay claimants’ “out-of-pocket expenses.” You won’t receive a free evaluation or replacement process from the company. Instead, you would have to pay for these costs and hope that Exactech will compensate you.
Furthermore, doing this could likely result in losing crucial rights in any future claims you may want to make.
Before contacting Exactech or Broadspire, we strongly suggest you speak with one of our attorneys first.
What Compensation Can Exactech Lawsuits Recover?
The following things might be covered by an Exactech knee, hip, and ankle recall settlement:
- Any medical treatment, like surgery, is required if the replacement device fails.
- Medical expenses (past and future)
- Suffering and pain (past and future) resulting from treatment, injuries, and recovery
- Lost income or wages
- Loss of ability to earn
- Loss of enjoyment in life
- Potential punitive damages
A defective Exactech knee, ankle, or hip replacement may have caused you to suffer damage, and the product liability attorneys at Hinds Injury Law Las Vegas will fight to get you the highest monetary compensation possible.
Exactech Lawsuit News Updates/Case Progression
May 23, 2023
The MDL (Multi District Litigation) Judge recently issued a new Case Management Order (CMO 3) that specifies specific rules and procedures for safeguarding tangible medical evidence like explanted implants, as the volume of ongoing Exactech recall cases within the class action MDL keeps increasing. A third-party healthcare evidence storage provider was recruited to serve as a repository for this material, which may be necessary for substantiating or supporting particular plaintiffs’ claims. Keeping proof of these implants’ deterioration is crucial for future legal proceedings or trials.
May 15, 2023
There was a significant increase in the variety of cases pending within the Exactech implant recalls for the second consecutive month. Over the past 30 days, 83 more cases involving flawed Exactech implants have been added to the MDL, which takes the number of active cases in the MDL to 373.
May 9, 2023
Tomorrow will mark “Science Day” in the MDL within Alachua County, Florida, which uses state court procedures. The event will start around 9 a.m. Eastern Standard Time on May 10, 2023, in Gainesville, Florida. Science Day’s topics include the following:
- Background information about joint replacement surgery and equipment
- How the devices work
- The materials or components of the devices
- The packaging and design of the devices
- How every device is produced
- The injuries claimed in this lawsuit
What does Science Day serve to accomplish? On Science Day, the litigants present the judge with scientific and technical information pertinent to the case. It is frequently used to help the court better comprehend the sophisticated scientific or technical ideas crucial to litigation in complex medical device disputes like the Exactech trial. Therefore, Science Day aims to inform the court regarding the science and technology associated with the subject without debating the case’s legal positioning or merits, even though lawyers are subtly doing this to some level.
May 1, 2023
In most mass tort cases, the defense counsel prefers to move slowly while the plaintiffs’ attorneys push for a trial. No exception applies to the Exactech class action lawsuit.
For instance, Exactech still needs to submit complete copies of any potentially relevant insurance agreements and basic information, including the names and contact details of people who may have relevant information, under Federal Rule 26. The plaintiffs, in contrast, have offered 337 Preliminary Disclosure Forms, which include information about implant and explant surgeries and related records that show a connection between the product and the harm. Exactech argues that Rule 26 disclosures were inappropriate for an MDL, yet plaintiffs find the lawsuit frustrating because there is a lack of essential information.
April 19, 2023
This month, the number of new Exactech implant recall lawsuits significantly increased. Over the past 30 days, 111 additional cases have been added to or transferred toward the Exactech class action lawsuit. The number of pending cases now stands at 290, marking the most significant monthly increase since the beginning of this litigation, and it begins a fresh trend that will last the entire year. More than 80 Exactech cases are ongoing in a Florida state court, MDL.
March 31, 2023
In a letter to the MDL court yesterday, the defense attorneys for the private equity firms that own Exactech requested a pre-motion conference about a motion to dismiss the plaintiff’s lawsuit against them. According to the letter, none of these businesses were involved in creating, producing, packing, or distributing the Exactech implants.
Plaintiffs are suing those companies because they exercised significant control over Exactech’s management and business decisions. The parent company’s dominance and influence over the subsidiary must be alleged to break through the corporate veil and reach these firms.
March 25, 2023
Exactech joint replacement devices made between 2004 and August 2021 received recalls in both 2021 and 2022 owing to improper packaging bags that could speed up device wear and failure and necessitate revision surgery. The FDA is warning patients and healthcare professionals about these products. Patients with adequately working devices do not require surgery but should still contact their doctor if they suffer new or worsening discomfort or swelling.
That connects to the claims made during the Varneckas case we covered yesterday. Exactech should have informed patients and doctors about their concerns before the recall because monitoring patients may help avoid bone loss and other problems.
The FDA advises healthcare professionals to avoid implanting recalled devices and to monitor patients for possible device wear, failure, or bone loss. A broader voluntary recall for ankle, knee, and hip replacement devices that were packaged in subpar bags has been announced by Exactech. The FDA is collaborating with the company to evaluate the hazards of other joint implants in comparable packaging.
March 24, 2023
Exactech cases are still being filed. Varneckas v. Exactach, a new complaint, was recently filed within the New Jersey class action. At the Hospital for Special Surgery in New York, the plaintiff, in this case, received bilateral total knee replacement surgery in February 2018. Optetrak Logic PSC Polyethylene Tibial Insert recall components were implanted in the woman. She experienced left knee revision surgery in April 2021 due to the insert’s accelerated wear. She also complains of pain in her right knee, which will probably need revision surgery to remove the last piece of the recalled polyethylene tibial implant.
She claims that the defendants intentionally and dishonestly failed to disclose to her and her medical professionals the severe hazards involved with the device and the requirement for diagnostic tests to quickly identify the sneaky process resulting in toxic polyethylene particles dissolving and causing osteolysis. According to her lawsuit, they were required to advise her surgeons to bring their patients back for routine radiologic monitoring for osteolysis and chemical deterioration of polyethylene, and their failure to do so resulted in substantial bone loss. She now experiences discomfort, poor balance, gait impairment, and trouble walking.
March 22, 2023
The Exactech implant recall class action MDL had 47 new cases as of last month, and the overall number of active cases now stands at 179. Additionally, it represents the highest monthly number of new cases since the MDL’s inception a year ago.
February 20, 2023
A “Science Day” has been scheduled for May 10 by the judge within the Exactech recall class action MDL. In mass tort MDLs concerning product liability lawsuits, science days are typical. They offer the attorneys for every side the chance to present before the court to inform the jury about the scientific problems and supporting documentation.
One hundred thirty-two cases are still pending inside the Exactech MDL, and at least 80 are still waiting in Florida state courts.
February 1, 2023
MDL Judge Garaufis completed the procedure in the Exactech class action in the last two weeks, enabling the direct filing of all ensuing cases in the MDL utilizing a short-form Complaint. To keep lawyers and the general public up to date on the MDL proceedings, Plaintiffs’ Liaison Counsel also developed a website to post court directives, deadlines, and other important information.
The parties shall submit a unified letter with suggestions for Science Day later this week. In 2023, class actions will frequently involve Science Day. The MDL judge will be informed about the scientific and medical issues in the case at this informal hearing for the lawyers of both parties.
January 20, 2023
Next week, the judge handling the Exactech implant recall at a status forum is anticipated to set deadlines for the parties to submit collaborative case management and discovery strategies.
Judge Garaufis received a joint status report from the attorneys for both sides on Tuesday documenting their work on various administrative duties and the current discovery stage in the 86 merged cases in Florida state court.
The report mentions that the plaintiffs in those Florida cases submitted master discovery requests in early December. Dr. Sharat Kusuma, the chief medical officer of Exactech, will be deposed on February 16, 2023.
January 14, 2023
Another notable instance of recent Exactech implant recall litigation is Hursey v. Exactech, Inc. et al. (1:22-cv-07893), brought within the Exactech recall class action MDL into the Eastern District of New York.
The Truliant Knee System from Exactech, which was called up in February 2022, is the implant product at issue in this case. Hursey underwent knee replacement surgery in July 2021, during which the Truliant was inserted. By August 2022, the polyethylene insert component failed, necessitating revision surgery.
Although other allegations were made, strict responsibility for a manufacturing flaw is Hursey’s primary cause of action in the complaint.
January 9, 2023
Hursey v. Exactech, Inc. et al. (1:22-cv-07893) illustrates a recent Exactech recall litigation filed in the Eastern District of New York. The Knee stabilization system by Truliant from Exactech is at issue in this case.
The Truliant system was implanted during Mr. Hursey’s knee replacement procedure. Later, he had to have revision surgery because of worsening swelling and pain. Hursey’s swelling and pain were brought on by the premature failure of the polyethylene insert within the Trulia during the revision surgery.
Hursey’s Exactech recall lawsuit alleges numerous causes of action against the company, with strict liability based on faulty manufacturing serving as the central defense.
January 7, 2023
Patients who have received a Truliant knee prosthesis will be followed up in a new study.
January 1, 2023
There are currently 80 Exactech litigation proceedings in the Florida state court version of the MDL, along with the Exactech recall actions pending within the federal court MDL.
Exactech’s attorneys wrote to MDL Judge Garaufis last week to emphasize the value of coordinating the discovery processes in state and federal court cases. To do this, Exactech submitted a motion within the Florida proceedings requesting coordination of federal and state discovery, and Exactech attorneys for the plaintiffs are contesting this motion.
December 27, 2022
Judge Garaufis agreed with the plaintiffs that steps should be taken to catch up with the Exactech state MDL currently ongoing in Florida courts at the inaugural status conference within the most recent Exact implant recall MDL. After last week’s session, Judge Garaufis approved the motion to permit additional Exactech recall claims to be brought directly into the MDL. Everyone finds it more straightforward as a result.
Additionally, he set several date extensions for the first MDL cleaning steps. The judge officially approved the appointment of 27 attorneys to fill various roles on the leadership committees for the plaintiffs in action. 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 implant recalls MDL in federal court. Florida’s legal system already has an MDL in state court.
With a first bellwether test trial scheduled for next year, the Florida state MDL is already running well ahead of the federal MDL regarding the timeline. That has led numerous attorneys on both sides to ask the federal MDL judge to speed up the proceedings to catch up.
Separate plaintiffs’ Exactech attorneys have written two letters to Judge Nicholas G. Garaufis requesting that he promptly permit straight filings within the federal MDL and appoint attorneys to the plaintiffs’ leadership committee.
November 8, 2022
The federal court system recently combined the Exactech implant recall complaints into a brand-new class action MDL. They also combined a state-level MDL class action from 50 Exactech claims involving recalled hip and ankle implants filed in Florida state courts.
Before the federal class action, a state court complaint against Exactech might go to trial. The first trial has been set for November 2023 by the judge overseeing the combined Exactech state court lawsuits in Florida. This case will serve as a de facto test trial bellwether for every Exactech lawsuit.
October 11, 2022
The JPML has formally combined the Exactech joint replacement recall claims into a new class action MDL. The Eastern District of New York will now serve as the primary venue for all legal actions concerning the recalled Exactech knee and ankle replacement implant systems.
Judge Nicholas G. Garaufis has been tasked with overseeing the MDL. President Clinton chose Senior Judge Garaufis to join the bench in 2000.
Although Exactech had been lobbying for the MDL to be established in the Northern District of Florida, Judge Garafis will now conduct a consolidated discovery procedure for the Exactech recall lawsuits, even if Exactech was not opposed to the consolidation.
Additional Exactech implant recall claims have sharply increased as a new class action MDL approaches. Exactech has faced 75 fresh recall cases since June 1 in federal courts, and groups of numerous plaintiffs are filing many regarding these new cases. With 75 new cases filed there, the Eastern District of New York remains the most favored venue. Unsurprisingly, many individuals who underwent surgery at the Hospital for Special Surgery in New York City come to our Exactech lawyers.
September 1, 2022
On September 29, 2022, arguments about whether to combine federal claims alleging Exactech joint failures due to manufacturing and design mistakes into a class action lawsuit will be heard by the U.S. Judicial Panel on Multidistrict Litigation. A significant step toward ensuring that the victims of the errors that caused the Exactech recall receive just settlement amounts is the certification of the MDL and the consolidation of all the litigation.
August 22, 2022
The Exactech recall has recently expanded. Exactech was compelled to broaden the scope of its recall of ankle and hip replacement implants. The implant recall that was started in February has been expanded to cover an additional 40,000 acetabular hip liner parts in the company’s Novation, Connexion, as well as other brand implant systems, according to a fresh recall notice letter that Exactech delivered to healthcare providers last week.
WHEN THIS EXTENDED RECALL IS ANNOUNCED, the JPML is debating whether to group the expanding number of Exactech implant recall lawsuits to a new class action MDL. Our attorneys find it difficult to imagine a situation where a fresh Exactech class action case needs to be filed. As soon as this month, the court should issue its decision.
August 1, 2022
Exactech, a maker of implants, filed a response to the most recent MDL action with the JPML on behalf of their client. Exactech recommended that the panel endorse grouping all federal courts Exactech implant recall litigation into a new MDL. Exactech concurred with the plaintiffs’ desire for the Eastern District of New York as the court’s location. That should make the JPML more likely to consent to create a fresh Exactech class action lawsuit regarding these recall cases.
July 1, 2022
Exactech announced a total recall for each knee and ankle replacement implant system about four months ago. However, most patients with faulty implants still have not heard about the recall.
Exactech offered orthopedic physicians a sample letter to advise patients about the recall when it was initially implemented in February. Although Exactech has provided an example patient letter, it must take additional steps to contact patients. Only a tiny portion of the estimated 150,000 patients with faulty Exactech implants have been informed of the recall.
Therefore, there isn’t a class action Exactech lawsuit, and the number of new recall claim litigation needs to be more active. Exactech was the target of nine brand-new product liability cases in federal courts in May, and in April, just nine Exactech recall cases were reported.
The Exactech recall reportedly covered 150,000 patients. But because Exactech has delegated responsibility for sending out patient notice letters to individual doctor’s offices, many of these individuals still need to be made aware of the recall. By the end of the summer, expect a significant increase in the number of Exactech recall lawsuits filed.
The Exactech class action case, which will eventually resolve all of these lawsuits at once, is being delayed by this poor progress. Exactech attorneys held out on asking for a class action until enough claims were filed before approaching the MDL Panel.
Exactech knee implant recalls claimants submitted a request to the Judicial Panel on Multidistrict Litigation (JPML) at the end of last month (June 2022) asking for establishing a new MDL for the Exactech class action case for the pooled handling of all upcoming Exactech recall claims.
Patients with a bad knee and ankle implants implanted filed a constant flow of product liability claims following the Exactech recall notice in February. There are 27 pending Exactech implant recall cases across eleven distinct federal districts, according to the motion submitted to the JPML.
According to the document, the Exactech class action lawsuit’s proposed venue is the Eastern District of New York. However, Exactech may request that Florida’s Northern District be its headquarters. (Revision: New York prevailed.)
What Is the Purpose of Ankle, Knee, and Hip Replacements?
The goal of ankle, knee, and hip replacement surgery is to treat painful and dysfunctional knee, ankle, and hip joints. Every joint replacement has a unique process.
Knee replacement surgery (arthroplasty)
People often undergo knee replacement surgery to treat the extreme pain brought on by osteoarthritis, according to the Mayo Clinic. Due to their pain, these people may find it challenging to move, get into and out of seats, and climb stairs. Sometimes the agony continues even when the person is sleeping.
During the replacement process, surgeons remove damaged cartilage and bone from the patient’s shinbone, thighbone, and kneecap. A prosthesis— an artificial joint made of metal alloys, premium plastics, and polymers—replaces the removed parts.
Total Ankle Arthroplasty (Ankle Replacement)
Ankle replacement surgery is performed to ease the pain associated with an arthritic ankle, similar to knee replacement surgery. An ankle fusion is an option for patients if anti-inflammatory medications, braces, or cortisone injections are ineffective in relieving their symptoms. In this procedure, the surgeon fastens broken bones together to unite into a single bone while healing. According to the Mayo Clinic, this treatment may successfully relieve pain, but it may limit the mobility of an ankle joint, leading to arthritis affecting nearby joints.
In contrast, during an ankle replacement procedure, the surgeon takes the patient’s broken bones’ ends and replaces them with a plastic and metal prosthetic joint. The possibility of arthritis in neighboring joints is lower because the patient can still move their ankle.
Hip Arthroplasty (Hip Replacement)
Diseases including rheumatoid arthritis, osteoarthritis, and osteonecrosis (when bone sections die from a reduction in blood flow) are frequently the causes of hip replacement surgery. Falls resulting in breaks and fractures could prompt someone to seek hip arthroplasty relief and functionality.
Among the largest joints in the body, the hip’s ball-and-socket joint is made up of the “ball” at the top of the femur (femoral head) that fits into the “socket” (acetabulum) of the hip bone in the pelvis.
During the hip replacement procedure, the surgeon makes an incision to remove the hip joint’s diseased or damaged bone and cartilage. The acetabulum and femoral head are then swapped for artificial ceramic, metal, or plastic components.
Who Can File an Exactech Lawsuit?
You might be eligible to file an Exactech case if you had to undergo surgery after getting a recalled Exactech hip, ankle, or knee implant or if your doctor urged you to do so. To confirm the implant you had, look through your medical records or get in touch with your orthopedic surgeon.
You can ask a product liability attorney for help if you are still determining what brand of implant you have. Devices produced between 2004 and August 2021 are subject to lawsuits.
You might be eligible to file a claim against Exactech if you experienced issues with any of the following implants:
- MCS Hip
- Acumatch Hip
- Optetrak Knee
- Novation Hip
- Truliant Knee
- Optetrak Logic Knee
- Vantage Ankle
Even though your doctor has not recommended surgery, if you experience any of the following symptoms, you may be eligible to file a lawsuit:
- Implant noise, such as clicking
- Inability to support the weight
Exactech recommends doctors speak with patients who have implants containing recalled devices. But if your doctor still needs to call you, contact their office to arrange a follow-up visit.
What Should You Do If You Were Impacted?
If you had a Connexion GXL liner or were affected by the recall, it is essential to get in touch with your physician so they can check your implant for early wear or bone loss. In the early phases of osteolysis or implant deterioration, you might not experience any symptoms.
You can submit a claim through Exactech or pursue legal action. If you file a case, speak with a lawyer as soon as possible to protect your ability. Most law firms give free case evaluations for product liability lawsuits, and you are not required to choose the first company you speak with.
When you speak with the attorney, bring your medical records and other relevant information about your implant. They will question your background and the kinds of wounds you have received.
You have appointed a law firm to represent you. After that, you sign an agreement with them. Typically, you are only charged a fee if they successfully get compensation for you.
Exactech Knee Replacement Implant Lawsuits
Manufacturers of medical devices, including Exactech, are required by law to guarantee their goods are risk-free when used for the intended purpose and without any dangerous flaws or defects. The Exactech recall letter acknowledges that the replacement implants for the knee and ankle were flawed. Therefore, it will be less challenging to hold Exactech accountable for damages and injuries as a result than it would be in a traditional 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 plaintiffs 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 their knee implant failure.
According to our attorneys, if you have a strong case, you have a significantly better chance of receiving an Exactech settlement than having your way to appear in court. Because other sources besides plaintiffs’ attorneys also provide testimony or evidence of Exactech’s faults. The statements made by Exactech following the recall give these cases their strength.
History of Problems with Exactech Knee Implants
There is a long history of issues with the Exactech knee replacement system, including high failure rates. To avoid going through the entire FDA review and approval procedure, Exactech has always gotten 501(k) abbreviated FDA clearance due to its knee replacement system. Exactech was mindful from the start that the failure rate of its OPTETRAK knee replacement implant system was much higher than that of competing products.
Exactech implants were noted as failing at an abnormally high rate in comparison to other implants in the FDA’s Manufacturer and User Facility Device Experience (MAUDE) report. This failure manifested early. The rising rate of events, of which Exactech was internally wary several years ago, is reflected in MAUDE reports. Exactech implant devices are currently the subject of so many complaints in MAUDE that a search is limited (to 500 results). As a result, not all Exactech complaints can be seen.
Users who had early implant failures filed product liability claims against Exactech in 2016 and 2017 due to these failures. Our attorneys have reviewed those lawsuits in the past. The lawyers who brought those complaints could not determine why Exactech knees were malfunctioning and were watching the issue from a distance. However, these Exactech lawyers could not fully comprehend why Exactech knees malfunctioned.
Early Exactech implant lawsuits recognized that the “finned” design element, specific to Exactech implants, was responsible for the high failure rate among these parts. That knee replacement lawsuit claimed that Exactech should have alerted consumers to this risk. Instead, they conducted a “silent” recall, gradually changing the finned design rather than recalling the products. However, the Exactech recall highlighted the particular oxygenation issue that contributed to the degeneration of these parts.
Exactech phased out the finned design, although this did not lower their implant systems’ excessively high failure rate. That eventually drove them to look into more potential issues, which led them to find the faulty vacuum-seal packaging that sparked the recall notice.
Exactech Received Expedited FDA Approval
Between 1994 and 2017, Exactech consistently received FDA 501(k) clearance for its Optetrak Logic, Truliant, and Optetrak total knee replacement implant components and systems.
The FDA’s 501(k) clearance is known as “fast-track” approval because the manufacturer is not required to vouch for the product’s efficacy and safety. The maker needs to describe the device’s substantial equivalence with a pre-MDA predicate device to receive 510(k) clearance via this route, commonly known as “premarket notification.”
Following that, the FDA might “clear” a modern device for sale throughout the U.S. The FDA granted 510(k) clearance for all of the component elements that make up the plaintiff’s Optetrak Device, or they were marketed without 510(k) clearance or full FDA approval.
The main flaw in the 510(k) process is that the device’s manufacturer can show that it is “substantially equivalent” to a predicate product that has already been on the market for some time. So, thorough testing is optional. These 510(k) goods frequently come up in product liability cases because, surprise, medical devices that have yet to be thoroughly examined are more likely to have flaws.
Knee Implant Lawsuit Against Exactech Logic Example
In New York’s federal court, initial post-recall claims involving Exactech knee replacements were submitted. Burke v. Exactech Inc., 1:22-cv-020806 (S.D. NY), was the case’s filing date in 2022. Exactech Optetrak Logic implants were placed in James C. Burke’s left and right knees in 2013 and 2016, respectively. Burke’s Optetrak Logic implant lasted for a brief time, and the lawsuit alleges that in the years after the operation, he experienced discomfort, instability, and bone loss. Burke eventually underwent a lengthy correction procedure in 2019. She retained a personal injury attorney to file a recall action against Exactech.
Burke’s Exactech cases of product liability lawsuits mainly rely on the company’s February 2022 recall notification for every Exactech knee and ankle replacement implant system. Burke’s lawsuit claims that the Optetrak implant proved faulty due to the package recall and early deterioration of the plastic liner inserts. He alleges that Exactech knew about these flawed inserts but carelessly should have alerted physicians and patients. Burke asserts in his Exactech recall lawsuit that the “accelerated polyethylene wear” in the Optetrak inserts was the primary cause of the early failure of his Exactech knee implants after only six years.
Ten different counts are made in the Burke complaint. But strict liability determined by a manufacturing flaw is the main premise of tort liability within the lawsuit. Burke asks for punitive and compensatory damages to cover his medical bills and misery.
File Your Exactech Recall Lawsuit
For clients, you should call our legal team at Hinds Injury Law Las Vegas at (702) 940-1234 to find out if you have a case where your Exactech knee replacement implant broke and you need corrective surgery.
If you have any questions or want more information, call us today or schedule an appointment or consultation.