Tag: exactech knee recall

Optetrak Patella Implant Device Exactech Recall

Posted on by Loni Liss

A letter was recently sent to surgeons, hospitals, and healthcare professionals announcing the voluntary recall of the Exactech Optetrak Patella implant device.

The voluntary Exactech recall concerns Patella lots that were packaged without the ethylene vinyl alcohol (EVOH) layer. Experts advised doctors not to implant these potentially harmful devices packaged in faulty packaging.

Medical professionals were advised to stop using the product immediately and set aside any that might be affected. They were instructed that healthcare professionals should report any adverse reactions or noticeable quality issues as patients come forward.

Our attorneys handle Exactech recall lawsuits nationwide. If you’ve experienced failure of an Exactech knee, hip, or ankle implant that was recalled, leading to revision surgery, we’re here to help.

Stay informed with the latest updates and insights on this page.

Don’t overlook your rights—contact our product liability lawyers at 800-967-8529 or online. You won’t incur any fees unless you receive financial compensation.

Exactech Optetrak Patella recalled medical device

Exachtech Addresses Oxidation Risk with Packaging Recall

From 2004 to August 2021, Exachtech used two types of packaging materials in its process: (1) Low-Density Polyethylene (LDPE), Nylon, and EVOH, or (2) LDPE and Nylon without EVOH.

EVOH improves the prevention of oxygen permeation. Thousands of devices were packaged without using an EVOH oxygen barrier layer, which potentially causes unintended oxidation and early degradation of the affected device.

Given the potential for oxidation-related issues, Exachtech voluntarily recalled these lots as a precautionary measure.

The recall emphasizes the importance of surgeons regularly monitoring patients with affected devices for signs of wear and failure. The crucial issue is determining how many thousands of patients might suffer from device-related pain or failure, potentially needing revision surgery.

knee replacement recall lawsuit by The Yost Legal Group

Stay Informed on Patella Device Recall and Risks

The lot-specific voluntary recall relates to Patella devices manufactured from 2004 through August 2021. These devices were marketed as Optetrak and cleared through 510(k): K932690, K933610, and K160484.

All healthcare professionals were instructed to review the following information and take any necessary actions. Then, the information advised diagnostic considerations, such as performing X-rays to evaluate the patient further if device failure is suspected.

Potential issues due to oxidation include:

–             Accelerated device wear or failure

–             Component cracking or fracture

–             New or worsening pain

–             Bone loss

–             Swelling in the affected area

Key Information on Optetrak Device Failures

The recall names all of these knee replacement devices, which could necessitate revision surgery for patients.

Part Number Device Description                                                         Device Identifier

200-02-26        THREE PEG PATELLA 26MM                                    10885862039576

200-02-29        THREE PEG PATELLA 29MM                                    10885862039583

200-02-32        THREE PEG PATELLA 32MM                                    10885862039590

200-02-35        THREE PEG PATELLA 35MM                                    10885862039606

200-02-38        THREE PEG PATELLA 38MM                                    10885862039613

200-02-41        THREE PEG PATELLA 41MM                                      10885862039620

200-03-26        ONE PEG PATELLA 26MM                                         10885862039637

200-03-29        ONE PEG PATELLA 29MM                                         10885862039644

200-03-32        ONE PEG PATELLA 32MM                                         10885862039651

200-03-35        ONE PEG PATELLA 35MM                                         10885862039668

200-03-38        ONE PEG PATELLA 38MM                                         10885862039675

200-03-41        ONE PEG PATELLA 41MM                                          10885862039682

200-05-23        INSET PATELLA 23MM                                              10885862039835

200-05-26        INSET PATELLA 26MM                                               10885862039842

200-05-29        INSET PATELLA 29MM                                               10885862039859

200-07-26        ADVANCED PATELLA 26MM 3 PEG IMPLANT  10885862314260

200-07-29        ADVANCED PATELLA 29M 3 PEG IMPLANT      10885862314277

200-07-32        ADVANCED PATELLA 32MM 3 PEG IMPLANT  10885862314284

200-07-35        ADVANCED PATELLA 35MM 3 PEG IMPLANT  10885862314291

200-07-38        ADVANCED PATELLA 38MM 3 PEG IMPLANT  10885862314307

Exactech lawsuits by The Yost Legal Group

The Hidden Dangers of 510(k) Fast-Track FDA Approvals

Between 1994 and 2017, Exactech secured multiple 501(k) clearances from the FDA for its Optetrak, Optetrak Logic, and Truliant total knee replacement implant systems and components.

The FDA’s 510(k) clearance, known as “fast-track” approval, does not require manufacturers to prove a product’s safety and effectiveness.

This process, known as “premarket notification” or 510(k) clearance, only requires the manufacturer to demonstrate that the device is substantially equivalent to a pre-MDA predicate device.

Consequentially, the FDA can “clear” a new device for sale in the USA. Under the 510(k) process, the component parts used in the Exactech Optetrak Devices were either approved by the FDA or marketed without receiving either 510(k) clearance or full approval by the FDA.

Simply put, not enough product development and testing was done to ensure product safety. This can lead to patient harm and potential recalls, which is precisely what has happened.

Protect Your Rights Against Defective Medical Products

At Yost Legal Group, our priority is ensuring patient safety and achieving effective outcomes for patients with life-altering defective medical products. Our knee replacement lawsuit attorneys will help you file a lawsuit to seek compensation.

Collaborative efforts are essential for the success of actions against medical device manufacturers—especially those who continuously market harmful products.

Our law firm is dedicated to defending the rights of individuals against powerful corporations. Accordingly, when huge medical device manufacturers like Exactech continue to put profits before people, we step in to level the playing field.

Learn about your legal rights. We can file a product liability case on your behalf if you have a defective medical device. The Yost Legal Group is filing the current personal injury lawsuits:

  • Knee replacement recall
  • Shoulder replacement recall
  • Hip replacement recall
  • Exactech lawsuits

Empowering Patients, Challenging Corporations

If you or a loved one had knee replacement surgery in the past ten years and are experiencing pain, a clicking noise, swelling, or any other medical concerns, contact your doctor immediately.

Contact The Yost Legal Group for a free and confidential consultation at 1-800-967-8529. Our personal injury law firm is committed to promptly and transparently addressing potential concerns. If you had knee replacement surgery and are affected by the Exactech knee recall, please contact us.

Hold Exactech accountable for the harm they’ve caused. Our legal team is committed to seeking justice and ensuring they change their ways. A product defect lawyer will file an Exacteck lawsuit on your behalf.

For more information or to discuss your case, call us at 1-800-967-8529 or click this link to request an appointment.

By pursuing an Exactech knee replacement lawsuit, you will help send a powerful message for change. You may qualify for a significant financial recovery.

At The Yost Legal Group, you never have to pay anything upfront. We only get paid after we settle your case. If there is no recovery, no legal fees or expenses are due. Our personal injury law attorneys will provide legal representation with a free case evaluation.

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Consumers are encouraged to report any adverse events or quality concerns related to this recall to the FDA through the MedWatch reporting system. You can go online at the FDA Medwatch Website or call 1-800-FDA-0178.

Urgent Exactech Recall of Defective Hip Liner

Posted on by Loni Liss

Exactech Recall Lawsuit; Connexion GXL Hip Replacement Liner

Exactech, a Florida based medical device manufacturer, has issued an FDA Exachtech recall of a number of its medical devices. The recall list includes:

  • Optetrak
  • Optetrak Logic
  • Truliant knee replacement products
  • Vantage ankle replacement products
  • Connexion GXL Hip Liner

The hip implant recalls are prompted by the plastic in these products wearing out much faster than expected and causing the devices to fail. Most of these products were marketed to last 15 to 20 years but are failing much earlier.

The failure leads to pain and complications that usually require additional revision surgery to correct the problems caused by these defective products. Exactech lawsuits are being filed for victims injured by the recalled products.

Exactech hip replacement recall

“Enhanced” Polyethylene Wears Out Causing Bone Damage and Potential Hip Replacement

Exactech uses a special type of polyethylene in its products known as UHMWPE (Ultra High Molecular Weight Polyethylene). Exactech claimed that this “enhanced polyethylene” enabled its products to wear less and last longer than the standard polyethylene used by other orthopedic implant manufacturers. The opposite has proven true.

The industry standard for orthopedic implants is cross-linked polyethylene. Cross-linked plastic is treated with gamma or electron beam irradiation, creating harder, stronger, and more wear-resistant plastic.

Vitamin E was added to the material in the mid-2000s, further improving hip liner longevity. This design has been patented, leading some manufacturers, such as Exactech, to design their own version of this plastic to avoid paying patent fees.

This is where Exactech’s Ultra High Molecular Weight Polyethylene comes into play. Exactech created this as a way of saving money. However, due to poor manufacturing, the actual resulting polyethylene was not treated the way the patented cross-linked polyethylene was during production.

This resulted in the existence of free radicals on the plastic’s surface, making it more susceptible to oxidation. The oxidation then led to knee implant failure and hip implant failure. Thus leading to hip replacement complications and knee replacement complications.

hip replacement surgery recall

Exactech’s Cost-Cutting Measures Lead to Critical Hip Replacement Failures

Exactech claimed that the product’s packaging caused early oxidation. However, the product is meant to be resistant to oxidation since it will still encounter oxygen while implanted inside the body.

The failure of this plastic, and by association- Exactech products, is the result of cutting corners to save money. This could have been avoided had Exactech used the patented cross-linked polyethylene that has proven to be highly successful in orthopedic implants.

Instead, countless individuals suffered harm and had to undergo a hip replacement simply to save the company a couple of bucks.

Many patients have to undergo a revision hip implant surgery and a revision total knee revision surgery. The cost-cutting measures created range of motion problems, soft tissue problems, and diminishing quality of life for many.

Exactech Connexion GXL Hip liner lawsuit

Exactech’s Connexion GXL hip implant is a medical device used in total hip replacements. It is a “metal on plastic” hip implant featuring a polyethylene plastic acetabular liner. These implants are failing due to the polyethylene liners deteriorating.

The deterioration exposes the metal, causing the metal components within the implant to rub together and break down prematurely.

Studies by orthopedic surgeons of the Exactech Connexion GXL liner published in medical journals have shown that this defective liner is prone to early failure.

When the plastic wears out, it causes severe bone damage called osteolysis, which often requires hip liner replacement surgery.

The Yost Legal Group is filing hip replacement lawsuits for individuals across the country. If you require a revision surgery of your joint replacement device, protect your rights by filing a lawsuit.

Symptoms of the Device Failure include:

  • Difficulty walking
  • Loosening of the implant
  • Joint Stiffness
  • Swelling and inflammation
  • Possible bone degeneration: osteolysis
  • Extreme Pain

High Failure Rates Lead to FDA Recall

In June 2021, Exactech recalled the Connexion GXL liner. This was because the medical community had concerns about its high failure rates from wear, which were leading to severe osteolysis.

This recall affected roughly 90,000 patients with the Connexion GXL Liner. Exactech also sent doctors an “urgent communication” letter warning about the higher failure rates.

In fact, Exactech recommended that Connexion GXL patients follow up with their doctor if they had received their hip implant in the last six years and had not had a follow appointment in the past 12 months.

Total knee replacement surgery

Optetrak, Optetrak Logic, and Truliant Knee Implants

Along with the Connexion GXL Liner, the recall also included:

  • 60,926 Exactech Optetrak knee implants
  • 60,518 Exactech Optetrak Logic knee implants
  • 24,727 Exactech Truliant knee implants
  • impacting nearly 150,000 patients with these products.

The same defective polyethylene inserts were also used in 1,561 Exactech Vantage ankle replacement systems, which have also been recalled.

The Optetrak, Optetrak Logic, and Truliant Knee replacement systems are considered metal-on-plastic devices.

Polyethylene cushions the joints between the metal components. When the polyethylene oxidizes, the device breaks down, debris breaks off into the body, bone loss occurs, and more.

Symptoms of a failing knee or ankle system present complications, including:

  • Pain
  • Swelling around the joint
  • Accelerated wear
  • Component fatigue
  • Component fracturing
  • Debris production
  • Osteolysis (bone loss)
  • Bone Fractures
  • Instability in the knee or ankle
  • Inability to bear weight

If you have an Exactech knee or ankle implant and are experiencing any of these symptoms, you may be entitled to financial compensation.

Exactech Attempts to Limit Rights of Patients

After the recall, Exactech hired a company, Broadspire, to contact individuals who had received the recalled products. They wanted to see if these individuals were experiencing any problems and if they might require additional surgery.

Broadspire offered minimal compensation for those suffering from complications, only to cover the cost of the revision surgery.

In return for a small payment, people had to give up their right to sue Exactech in the future. This meant they couldn’t get money for the pain they went through.

Exactech hired Broadspire to save the company money. They are looking out for Exactech, not the people harmed by their defective devices.

If you have any of the recalled Exactech products and are suffering from complications, DO NOT sign an agreement with Broadspire. Doing so will waive your right to claim full compensation for the pain and suffering caused by this Exactech defective product.

You May Have a Claim for Compensation

If you or a loved one have a total knee replacement that has failed, you may qualify to file a lawsuit for financial compensation.

If you have one of the hip replacement recall devices, you may qualify to file a lawsuit.

If you had any joint replacement surgery that required being removed and replaced, call The Yost Legal Group to learn about your rights.

Do not sign anything from Exactech or Broadspire without speaking with an Exactech lawyer first. Doing so could limit your right to sue for full and fair compensation.

If you have questions, call The Yost Legal Group at 1-800-YOST-LAW (1-800-967-8529) today. We will provide a free case evaluation, or email us at info@yostlaw.com.

Our experienced Exactech attorneys can help you pursue your Exactech claim. We are investigating claims for individuals who are seeking Exactech settlements. There is no fee or expense unless you recover.

Exactech Hip Replacement Lawsuit Update 2023

Posted on by Loni Liss

Protect your rights by filing an Exactech Hip Replacement Lawsuit. Exactech is a global medical device company that creates orthopedic implant devices and surgical instrumentation for joint replacement surgeries. As a result of premature device failure, thousands of people require revision surgery or have developed serious health issues, such as Osteolysis.

If you or a loved one had any of the following surgeries, and the Exactech implant was used, you may qualify to file a claim against Exachtech.

– knee replacement surgery

– hip replacement surgery

– ankle replacement surgery

Did you have revision surgery for your hip replacement, knee replacement, or ankle replacement?

Did you receive a letter saying you require revision surgery?

Have you been diagnosed with Osteolysis after having hip, knee, or ankle replacement surgery?

Did you have hip replacement complications from the Exactech hip recall?

knee revision surgery after a defective exactech medical device

Protect yourself with the help of experienced Exactech lawyers

If you answered yes to any of the above, contact The Yost Legal Group at 800-967-8529 for a free, confidential consultation. We will answer your questions and inform you about the current Exachtech litigation. You may qualify to file a Hip Replacement Lawsuit.

Lawsuits have been filed against Exactech by victims seeking compensation for:

– past medical expenses

– future medical expenses

– pain and suffering

hip revision surgery after a defective exctech recall lawsuit

Exactech Hip Replacement Lawsuit Timeline

May 2023

Judge Donna Keim of Gainesville, FL, organized a special “science day” focused on Exactech implants. Two esteemed judges, Judge Nicholas Garaufis and Judge Marcia M. Henry from the Eastern District of New York, were invited to participate.

During this unique gathering, experts representing the plaintiff and defense sides of the Exactech lawsuit shared valuable insights on various aspects of the case.

Topics included the science behind hip and knee replacements, revisions, the materials used in the recalled Exactech implants, and the packaging materials. Additionally, other issues related to the recalled devices were also addressed.

Science Day was a significant opportunity for the judge to deepen her understanding of the recalled devices and raise pertinent questions. Moving forward, regular case management conferences will be held by the judges as the discovery phase progresses in the Exactech lawsuits. This ensures a thorough and practical examination of the matter at hand.

March 2023

The FDA warns patients and healthcare providers who have used Exactech joint replacement devices between 2004 and August 2021. They communicated about the recall of specific devices manufactured during this period.

The recalled Exactech joint replacement devices, including knees, ankles, and hips, were found to have been packaged in defective packaging bags. These bags lacked an essential oxygen barrier layer, which serves to protect the devices from oxidation – a chemical reaction that can deteriorate plastics over time.

The consequences of oxidation can be severe, resulting in accelerated device wear/failure, as well as component cracking or fracture. These issues may ultimately necessitate corrective revision surgery. It is important to note that some of the recalled devices are also associated with an increased risk of revision surgeries and bone loss due to excessive device wear/failure.

The FDA urged patients and healthcare providers to be aware of this recall and take the necessary steps to address potential risks or concerns. It was advised to contact the appropriate healthcare professionals to discuss further actions, such as device replacement or additional monitoring.

January 2023

Exactech pushes for official coordination and consolidation of federal and state court litigations related to the Exactech implant recalls.

December 2022

A rapid increase in lawsuits related to the Exactech recall has been filed into the Exactech MDL 3044.

October 2022

Due to the volume of cases filed, lawsuits involving the recalled knee and ankle products were consolidated into a Multi-District Litigation (MDL) in the Eastern District of New York. Similarly, many recalled hip and ankle products filed in Florida remain consolidated in the Florida state courts. Over a year later, over 850 lawsuits are pending in the MDL, and over 200 are pending in the Florida courts.

February 2022

To avoid paying patients what they truly deserve, Exactech chose early on to provide a settlement option upfront for its victims. Exactech retained the services of Broadspire, a third-party settlement administrator and risk management firm, to handle the claims reimbursement process.

Patients were encouraged to file a claim with Broadspire and obtain reimbursement for their out-of-pocket medical expenses only.

Essentially, Broadspire was hired by Exactech to lure victims in by appealing to people’s desire for quick money without the need for a lawyer. However, it is essential to remember that Broadspire is a risk management company whose sole purpose was to minimize the financial damage to Exactech.

The Broadspire settlement option only reimburses patients for medical expenses paid that insurance did not cover. This significantly reduces the amount of financial compensation Exactech will have to pay out.

Lost wages, related medical bills, and non-economic damages, such as pain and suffering, are not part of the calculus. A settlement through Broadspire will NOT compensate you for all of your damages.

Submitting a claim through Broadspire will impact your legal options against Exactech.

June 2021

Exactech issued recalls of its knee, hip, and ankle implant systems. They said defective packaging caused the polyethylene inserts to oxidize and deteriorate rapidly. This ultimately led to a premature failure of the devices.

At The Yost Legal Group, patients’ well-being is our top priority. We are here to provide support and guidance throughout this process. Please stay informed and take the necessary precautions to ensure your safety. 

Get the compensation you deserve for a Defective Exactech Medical Device

If you or a loved one has an Exactech hip or knee implant and still need to file a claim against Exachtech, call one of our experienced Exactech lawyers for help. A product liability lawyer at The Yost Legal Group will fight to recover your maximum settlement.

Even if you have already received a settlement through Broadspire, we strongly advise you to speak with one of our knee replacement recall attorneys today.

Call The Yost Legal Group at 1-800-YOST-LAW (1-800-967-8529) or email us at info@yostlaw.com today for a free consultation. There is no fee or expense unless you recover.

If you had an Exactech knee replacement failure or revision hip replacement, we would file an injury claim for you. Our injury lawyers will review your medical records and analyze the premature wear of your medical device.

We will talk with you about your loss of “quality of life” because of your failed medical device and how it has impacted your life.

The Yost Legal Group has years of experience handling defective product cases. We will file an Exactech lawsuit and ensure your rights are fully protected. If you have a failed knee replacement or failed hip replacement, call us.

We will support your fight for justice and hold Exactech rightfully accountable for their defective products.

The Yost Legal Group personal injury lawyers are filing exactech recall lawsuits for patients injured from the defective exactech hip replacements

Why contact The Yost Legal Group personal injury lawyers

Our personal injury law attorneys have years of experience representing medical malpractice, product liability, and defective medical device claims. We are filing Exactech lawsuits against the manufacturer. The Exactech recall has affected thousands of patients.

An Exactech recall lawsuit will protect your rights to receive financial compensation to cover your pain and damages.

Our Exactech attorneys are here to explain the hip implant failure lawsuit and knee implant failure lawsuit. If you have had a hip revision surgery or knee revision surgery due to a defective Exactech implant, we are here to help.

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DO I HAVE A CASE?

Contact us at the Yost Legal Group for a free initial consultation. We can help to provide information about ongoing litigation or discuss the circumstances of your individual case. There is no fee or expense unless you recover.