Exactech Knee, Hip and Ankle Device Recall

Exactech Joint Device Recall
Knox Boteler – Boteler Richardson Wolfe

(April 6, 2022) Medical device company Exactech, Inc has issued a recall for thousands of devices used in knee, hip, and ankle replacements. The plastic may wear early, leading to implant failure and revision surgery. Now patients who had an Exactech hip, knee or ankle device surgically implanted and experienced an early failure event can file claims against Exactech for compensation.

In a formal announcement February 7, 2022, Exactech directed orthopedic surgeons and facilities to notify patients immediately if their procedures involved the Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts. The devices fit in between metal components in knee and ankle replacements to cushion joints. When defective, the failing device may result in joint stiffness, pain, and degeneration of bone requiring revision surgery. As an FDA Class II Medical Device Recall, use of the product “may cause temporary or medically reversible adverse health consequences.”

What are Exactech Joint Replacement Systems?

Exactech is a global medical device company based in Gainesville, FL specializing in surgical implants specific to joint replacement surgeries. In 2021, Exactech announced troubling findings with its line of hip, knee, and ankle arthroplasty polyethylene inserts. These systems have been used in more than 150,000 knee, hip, and ankle replacement surgeries since first introduced in 2004.

Why Your Exactech Joint Replacement Could Fail

In its February statement, Exactech said its recall was based on non-conforming packaging that failed to protect the devices from early exposure to oxygen. Vacuum-seal bags were defective, allowing exposure and potential oxidation of the polyethylene liners used in many of Exactech’s hip, knee, and ankle devices. The resulting premature breakdown may lead to a broad range of serious discomfort demanding correction by revision surgery.

What’s the Solution if I Have a Failing Exactech Device?

A failed insert component may begin to degrade, fracture or crack over a short period of time relative to typical implant devices. Joints may become stiff and painful, eventually requiring corrective revision surgery. According to the American Association of Orthopedic Surgeons (AAOS), successful knee and hip replacements last 10-20 years for 90% of patients. Studies involving the Exactech products found a much higher rate of failure.
While revision surgery would be the corrective step, the procedure is typically more complex and lacks the same lifespan as a successful first-time joint replacement. Accumulated trauma, scar tissue and mechanical breakdown of components lead to diminished performance. All to say, revision surgery may be required for function, but is not a guarantee of optimal results. No one should wish for a second knee, hip, or ankle surgery.

Exactech Hip Device Recall

In June 2021, Exactech issued an FDA Class II Medical Device Recall of its Exactech Connexion GXL acetabular polyethylene liners used in hip implants. Although the company referenced “risk of edge-loading and premature prosthesis wear” as a possibility in a certain sub-group of patients with specific implant configurations, studies have shown a broader link between catastrophic early polyethylene wear and the use of the Exactech Connexion GXL liner. These studies found the average length between initial implant and diagnosed hip implant failure to be five years or less.

Exactech Knee and Ankle Recall

In February, 2022, Exactech broadened the recall to several of its knee and ankle systems, again due to concerns that the polyethylene liners lead to accelerated excessive wear, bone loss, and device failure requiring revision surgery. The recalled knee and ankle systems include Optetrak (knee), Optetrak Logic (knee), Truliant (knee), and Vantage (ankle). As with the Exactech Connexion GXL hip liners, the tibial inserts/liners used in these knee and ankle implant systems are exhibiting early polyethylene wear, causing the devices to fail.

What Should I Do if I have an Exactech Implant?

You should have received a formal notice from your orthopedic surgeon or clinic if your surgery involved an Exactech device included in the recall. However, with a recall covering procedures from 2004-2022, don’t rely on the notice alone to determine whether you may be impacted. Your best bet would be to reach out to your treating physician directly. (find out whether your surgeon uses Exactech devices)
Surgeons have been advised to discontinue using the Exactech knee and ankle replacement systems in all patients, and devices returned to the manufacturer. For those who already have one of the recalled systems implanted, the company is advising doctors to maintain a patient index and to closely monitor for signs of potential device failure.
How will you know if you have a problem? Symptoms of an Exactech replacement system failure include:
• Pain
• Stiffness
• Inability to bear weight on joint
• Instability in the knee or ankle
• Grinding noise in joint and/or swelling

If you are experiencing any of these issues, your surgeon will order X-rays to determine whether device insert decay is leading to failure.
If the patient is not experiencing pain, decreased mobility, or other adverse symptoms of implant failure, preemptive surgery to remove the device is not recommended.
Your surgeon will determine whether your failed joint requires surgical removal and replacement.

Exactech Implant Claims

You may be entitled to compensation if you had a recalled Exactech replacement system surgically implanted in your knee or ankle and the insert component of that system failed.
Manufacturers like Exactech have a legal obligation to ensure that their products are safe in their design, manufacture, and packing and that they do not cause harm. Exactech’s recall acknowledges that all knee and ankle replacement products made since 2004 were defective and subject to high failure rates.

Compensation for Need for Second Surgery

Patients who required corrective revision surgery because of a defective Exactech implant can file a claim against the manufacturer and seek compensation. Compensation from a successful claim could include monetary damages for pain and suffering as well as medical expenses incurred out of pocket for surgery or related medical treatment. Damages for lost income may also be awarded.
With the 18-year span of the components recall, it is still best you speak with your treating orthopedic regarding any potential impact on your health

For more information related to this post, please contact Boteler Richardson Wolfe at 251.433.7766 or email us at knox@brwlawyers.com

Personal Injury Claim? It Pays to Get a Second Opinion

Marcus and Latoya Golden

When Latoya Golden’s 17-year-old son Marcus was injured in a car crash, she decided to use a TV lawyer to help her son with his case. After several months of not hearing any follow up, she finally got a call: the attorney wanted to simply settle the claim. “When he told me he was going to settle I was happy at first,” she said. “But then he told me how much would be left for Marcus after attorney fees and medical bills, and I felt it was just too low.” Over the next few weeks as the attorney continued pushing for a settlement, Latoya decided it was time for fresh advice.  She opted for a second opinion on her personal injury claim and took her son’s case to Mark Wolfe of Boteler Richardson Wolfe – Injury Lawyers. After the meeting with Mark, the case file was transferred to him.

“Marcus’ claim was interesting in that he had health insurance, but the hospital that treated his injuries opted not to bill it,” said Wolfe. “Instead, they filed a hospital lien against his insurance claim for the full balance of their service.”  Wolfe advises this is not uncommon in car crash cases, but often the lien can be negotiated down to the same amount as the health insurance provider would have paid.  In addition, Marcus had other damages that had not been previously documented when the other lawyer had presented the claim.  “When I took on the case, I felt confident we could get the hospital lien reduced and the overall settlement amount increased. Our fee was only charged against the additional benefit we won for Marcus.”

He was right. After several weeks of work, Mark was able to double the amount of money Marcus recovered from his accident.  Wolfe credits a team effort to pull together a great client result. “Our staff is used to navigating the technicalities of hospital liens and negotiating reductions for their repayment,” he said.  “When a firm like ours has years of litigation experience in car crash cases and a record of meaningful verdicts and settlements – insurance companies realize who they’re working with.  That experience helps to convince a claims adjustor to rethink… and up the offer on a settlement.

None of this was lost on Latoya, who was quite happy with the result for her son.  “Marcus can now afford a car to help him with transportation, and when he turns 19, he’ll get another check,” she said enthusiastically.  When asked about her experience with the two lawyers, she described the difference as night and day.  “Mr. Wolfe and his office kept us informed every step of the way. He told us what he was going to try and do and how he thought he could benefit Marcus. He was always available to answer my questions. I felt like the other lawyer just wanted to get my son’s claim over with as quickly as possible and wasn’t really concerned about helping Marcus.”

The Alabama Rules of Professional Conduct allow attorneys to provide second opinions about a legal matter. If you would like a second opinion about the value of your personal injury claim or case call Mark Wolfe today at 251 410-7761 to discuss the proper protocol and procedure to get a second opinion. 

Alabama Bike Crash Law – Know the Legal Road

Alabama Bike Crash Law
Mark Wolfe – September 2021

It’s not surprising we represent dozens of injury and death claims related to cycling crashes every year. That’s because Alabama bike crash law and safety consistently falls near the bottom of the annual ranking by bike safety advocacy organizations. A lack of infrastructure allowing motorists and cyclists to safely share the road; weak legislation and enforcement; and general anti-bicyclist bias leave Alabama 45th out of 50 on the 2019 Bicycle Friendly State Report Card.

For the past 20 years I’ve taken part in bike races and triathlons as an avid part of the Mobile Bay-area bicycle community.  Groups of us gather on early mornings or late afternoons to ride together in large safe numbers, well-outfitted in safety gear and lights, following every safety rule of the road.  Still, most all of us can count some injury from an accident or crash involving a motorist.

A Seasoned Cyclist and an Everyday Danger

In a recent case, we recovered damages for a local cyclist hit and injured after a careless driver ran a stop sign.  Amy was riding in the mid-afternoon, wearing highly visible attire and a helmet with headlight.  She proceeded with the right of way when the driver failed to pay attention and drove right into her.   Fortunately, the helmet saved her from serious injury.  While not a high-profile or high-dollar case, we vigorously fought for the compensation she was due in not only a defense of her rights as a cyclist but a statement of advocacy for those who enjoy biking across Alabama.

Why Alabama’s Contributory Negligence Law Matters

First and foremost, it’s essential to understand Alabama bike crash law for all ages. Alabama bicyclists are required to follow the same traffic laws as any other driver.  When those “rules of the road” are violated or a bicyclist is negligent, the results can be tragic.  Alabama is one of just two states with a contributory negligence law. Contributory negligence means even in a crash resulting in injury or death, you may forfeit the right to pursue damages in a civil lawsuit if the other party can establish any negligence on your part. Alabama law regarding contributory negligence is especially tough. Essentially, if an injured person is just one percent at fault for causing an accident, they may be precluded from any recovery. For example, Alabama law requires a red rear reflector on bicycles for nighttime riding. Using “blinkys” (battery powered blinking lights) instead of a red rear reflector could be enough to establish that the rider was partially at fault, thus precluding any recovery of money for injuries suffered in the accident – even if the motor vehicle operator was 99 percent at fault for causing the accident.  Failing to follow basic Alabama traffic rules may impact your claim for damages and even result in criminal penalties of your own.   Make sure you understand the law.

Alabama Bicycle Law

Alabama Code applies all state traffic laws to bicyclists as well: “Every person riding a bicycle upon a roadway shall be granted all of the rights and shall be subject to all of the duties applicable to the driver of a vehicle by this chapter, except as to special regulations in this article and except as to those provisions of this chapter which by their nature can have no application.

Under the Code, it is illegal for a bicyclist to:

  • Transport more people than a bicycle is designed or equipped to hold;
  • Attach himself or herself to another vehicle while riding upon a bicycle;
  • Ride more than two abreast, unless doing so along a specifically designed bicycle path;
  • Share the road with other vehicles when an adjacent bicycle path has been provided;
  • Transport packages or articles that prevent him or her from keeping at least one hand on the bicycle’s handlebars;
  • Ride his or her bicycle on a sidewalk or sidewalk area unless it is to access a driveway.

Bicyclists are also required by law to:

  • Stay as far to the right side of the road as feasibly possible;
  • Equip their bicycles with a white light lamp on the front for nighttime riding, which can be seen by oncoming drivers from at least 500 feet away;
  • Equip their bicycles with a solid red reflector on the rear, which can be seen by a vehicle traveling anywhere from 100 feet to 600 feet behind the bicyclist;
  • Have their bicycles equipped with a brake capable of making a skid on dry, clean pavement.

Bike Helmets Are a Must

Alabama law requires those under 16 to always wear an approved helmet when operating a bicycle, or when riding as a passenger on any public roadway or path. Child bicycle passengers who are less than 40 inches tall or who weigh less than 40 pounds must be properly secured in a bicycle-restraining seat, in addition to wearing an approved helmet.  Parents may be liable if they knowingly allow their children to violate any of these laws.  Is your 13-year-old out riding without a helmet? You could face legal trouble.

Tips to Help Keep Cyclists Safe

As a bicyclist, or a parent of children who ride bicycles, it’s important to not only understand Alabama bike crash law but safety measures that can keep you and those you love safe.

  • Abide by the helmet law at all times. Even if your age does not require it, this safety feature is critical in helping riders avoid a serious head trauma in the event of an accident or collision. The most serious and potentially deadly cycling injuries involve head trauma. Wearing a helmet saves lives.
  • Never ride on sidewalks. Ride along the right side of the road, as close to the curb as possible, or along designated bicycle paths. This way you will not put unsuspecting pedestrians at risk.
  • Carefully observe parked vehicles. When riding past parked vehicles, move far enough to the left so that you can avoid colliding with an open door.
  • Make sure your bicycle has a working front headlight and red rear reflector.
  • Follow the rules of the road. If you are sharing the road with other drivers and vehicles, you must adhere to the same rules and regulations.
  • Be especially vigilant at driveways and intersections. While you may be able to see the other driver or vehicle, never assume they can see you.
  • Wear bright clothing whether riding during the day or at night. Reflective clothing and lights can also help you remain visible to vehicles traveling in any direction.
  • Keep your eyes on the road. Your senses of sight and hearing can save you from a tragic accident. Stay alert – headphones can be a distraction.
  • Use hand signals to indicate turns. Be sure to give yourself enough room to exercise your intended turn or lane change.


What is Alabama’s Three-Feet Law?

Alabama approved a “Safe Passing Law” in 2015, requiring motorists maintain a minimum 3-feet space between their vehicle and any bicycle it approaches and passes.    The problem? It only applies when there is a marked bike lane, on certain higher-speed roadways, or when a bicyclist legally rides within two feet of the right shoulder of a roadway. These limitations are severe and undermine the law’s ability to protect a cyclist.

Alabama is now putting federal dollars to work on several bicycling and walking projects – a trend in the right direction.  Laws that better encourage and protect cyclists and pedestrians; and a commitment to Complete Streets with future road planning would do much to improve Alabama’s dismal Bicycle Friendly report card rating.

What If I’ve Been in a Bike Crash?

First and foremost, we don’t call them bike accidents, and neither should you. The word “accident” implies the incident was “unavoidable.”  There’s a big difference in an accident… and a crash. Consider the safety tips below:

  1. Always carry a cell phone, personal identification, emergency contact and something to write with.
  2. Dial 911: call the police or an ambulance immediately. If you are unable to do so, ask for help.
  3. Always wait for the police to arrive and file an official report. A police report provides documentation detailing the incident, including the identity of witnesses.
  4. Get the business card of the officer.
  5. Leave your bike in the same state it was after the crash, if possible. It is best if the police see the accident scene undisturbed.
  6. Were there witnesses? Make sure to obtain their contact information.
  7. Immediately seek medical attention, either at the scene, the emergency room, hospital or doctor’s office. If in doubt, always go to the ER. Medical records are proof of your injuries and their extent.
  8. Take photos of injuries and your bicycle.
  9. Never negotiate with the driver of the vehicle, regardless of who may be at fault. Get the driver’s name and his or her insurance information, along with the names of any passengers.
  10. Make no statement to insurance until you talk to a lawyer.


Get Involved

The Alabama Bicycle Coalition provides an in-depth look at how the Alabama State Code applies to bicycles and bicyclists, along with advocacy programs and events statewide. There are plenty of ways to support legislation and awareness programs to make sharing the roads safer for all of us.

If you or a loved one has been involved in a bicycle crash, make sure to consult an attorney seasoned in Alabama bike crash law.  We’re passionate about the rights of cyclists and ensuring your compensation when another driver is at fault. Please call us for a no-fee no-pressure consultation: 251.433.7766.