Exactech Joint Replacement Recall

Exactech was founded in 1985 by surgeons who wanted to bring a medical perspective into a company in order to help others provide better patient care. However, some of Exactech’s knee, hip, and ankle joint replacement prosthetics were recalled due to faulty liners and inserts.

The recalled liners and inserts were kept in faulty packaging that caused them to be exposed to oxygen. This resulted in the polyethylene in the liners and inserts degrading, which could cause the joint replacement prosthetic to fail.

While joint replacements typically don’t last forever, they should last on average between 10 and 15 years. However, with the degradation of the Exactech polyethylene liners and inserts, the joint prosthetics could fail much sooner than that. Patients would then have to undergo revision surgery, which can be costly and risky, much sooner than they’d anticipated, on top of having a joint replacement that didn’t reduce their pain or improve their quality of life. Because of this, many patients have filed lawsuits against Exactech.

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What Is a Joint Replacement?

A joint replacement is a medical device that is surgically implanted into a patient’s body in order to replace a damaged joint. The joint replacement may replace the joint either in part or in full. The artificial joint is, like artificial limbs that exist outside of the body, called a prosthesis. In the case of a joint replacement, the prosthesis must be inserted into the body via surgery and takes the place of bone that must be removed during the surgery process to make room for the prosthesis.

What Is a Joint Prosthesis Made of?

A prosthetic for a joint replacement can be made out of the following materials:

  • Plastic
  • Metal
  • Ceramic
  • A combination of the above materials

Who Needs a Joint Replacement?

Many people who have joint pain don’t need joint replacements. A doctor typically considers a joint replacement when the joint has limited functionality, there’s moderate to severe pain, and the problem is limiting the patient’s quality of life. Those who undergo joint replacement surgery do so because they need it in order to alleviate pain and to live a normal life. They rely on the joint replacement for getting around and normal functioning and when something goes wrong with a prosthetic joint and further surgery is needed, that can negatively impact the patient’s quality of life, and necessitate revision surgery sooner than anticipated to repair the problem.

Who Is Exactech?

Exactech is a medical device company that manufactures joint replacements, in particular, knee, ankle, and hip replacements. The company was founded in 1985 by surgeons, Drs Miller and Petty, who wanted to create a medical device company that operated with the insight of doctors, for doctors, in order to improve patient care.

What Joint Replacement Prosthetics Does Exactech Produce?

Exactech produces the following joint replacement prosthetic devices:

  • Shoulder
  • Knee
  • Hip
  • Ankle
  • Foot

Why Were Exactech Joint Replacement Devices Recalled?

The Exactech joint replacement prosthetic devices that were recalled were affected by faulty packaging. The plastic bags in which the polyethylene liners and inserts were stored weren’t up to specifications and therefore the devices were exposed to oxygen. This exposure meant that once the liners and inserts were in place in a patient’s joint, they began to degrade, which in turn caused the joint replacement to fail much more quickly than it should have. Joint replacement failure can be painful and can cause other 

Which Exactech Joint Replacement Devices Were Recalled?

Exactech had a variety of joint replacement devices that were impacted by the recall of the polyethylene liners and inserts due to faulty packaging. The following devices were affected by the recall:

  • Hip replacement
    • Connexion GXL acetabular liner
  • Knee replacement
    • OPTETRAK® TKR All-polyethylene Tibial Components
      • OPTETRAK® All-polyethylene CR Tibial Components
        • 200-11-XX
        • 200-12-XX
        • 200-13-XX
        • 200-14-XX
        • 200-15-XX
        • 200-16-XX
      • OPTETRAK® All-polyethylene CR Tibial Components
        • 204-11-XX
        • 204-12-XX
        • 204-13-XX
        • 204-14-XX
        • 204-15-XX
        • 204-16-XX
    • OPTETRAK® PKR All-polyethylene Tibial Components
      • OPTETRAK® All-polyethylene UNI Tibial Components
        • 252-12-XX
        • 252-13-XX
        • 252-22-XX
        • 252-23-XX
    • OPTETRAK® TKR Tibial Inserts
        • 200-56-XX
        • 200-61-XX
        • 200-62-XX
        • 200-63-XX
        • 200-64-XX
        • 200-65-XX
        • 200-57-XX
        • 200-71-XX
        • 200-72-XX
        • 200-73-XX
        • 200-74-XX
        • 200-75-XX
        • 200-21-XX
        • 200-22-XX
        • 200-23-XX
        • 200-24-XX
        • 200-25-XX
        • 200-26-XX
        • 200-50-XX
        • 200-51-XX
        • 224-21-XX
        • 224-22-XX
        • 224-23-XX
        • 224-24-XX
        • 208-21-XX
        • 208-22-XX
        • 208-23-XX
        • 208-24-XX
        • 208-25-XX
        • 208-51-XX
        • 204-21-XX
        • 204-22-XX
        • 204-23-XX
        • 204-24-XX
        • 204-25-XX
        • 204-26-XX
        • 204-50-XX
        • 204-51-XX
        • 204-91-XX
        • 204-92-XX
        • 204-93-XX
        • 204-94-XX
        • 204-95-XX
    • OPTETRAK® TKR HI-FLEX® Polyethylene Tibial Inserts
      • OPTETRAK® HI-FLEX® PS Polyethylene Tibial Inserts
        • 244-20-XX
        • 244-21-XX
        • 244-22-XX
        • 244-23-XX
        • 244-24-XX
        • 244-25-XX
    • OPTETRAK® TKR Custom Polyethylene Tibial Inserts
        • 900-33-XX
        • 900-23-XX
        • 900-30-XX
        • 900-06-XX
        • 900-08-XX
    • OPTETRAK® LOGIC® TKR Polyethylene Tibial Inserts
      • OPTETRAK® Logic CC Tibial Inserts
        • 02-012-65-XXXX
      • OPTETRAK® Logic CRC Tibial Inserts
        • 02-012-51-XXXX
      • OPTETRAK® Logic CR Tibial Inserts
        • 02-012-47-XXXX
      • OPTETRAK® Logic CR Slope + Tibial Inserts
        • 02-012-48-XXXX
      • OPTETRAK® Logic CR Slope ++ Tibial Inserts
        • 02-012-49-XXXX
      • OPTETRAK® Logic PS Tibial Inserts
        • 02-012-35-XXXX
      • OPTETRAK® Logic PSC Tibial Inserts
        • 02-012-44-XXXX
    • OPTETRAK® RBK® TKR Polyethylene Tibial Inserts
      • OPTETRAK® RBK PS Tibial Components
        • 264-21-XX
        • 264-22-XX
        • 264-23-XX
        • 264-24-XX
        • 264-25-XX
    • OPTETRAK® Logic RBK TKR Tibial Components
      • OPTETRAK® Logic RBK PS Tibial Components
        • 02-012-38-XXXX
    • ARTHROFOCUS® TKR Polyethylene Tibial Inserts
      • ARTHROFOCUS® Polyethylene Tibial Inserts
        • 256-12-XX
        • 256-13-XX
    • TRULIANT® TKR Tibial Inserts
      • TRULIANT® CRC Tibial Inserts
        • 02-022-51-XXXX
      • TRULIANT® CR Tibial Inserts
        • 02-022-47-XXXX
      • TRULIANT® CR Slope + Tibial Inserts
        • 02-022-48-XXXX
      • TRULIANT® CR Slope ++ Tibial Inserts
        • 02-022-49-XXXX
      • TRULIANT® PS Tibial Inserts
        • 02-022-35-XXXX
      • TRULIANT® PSC Tibial Inserts
        • 02-022-44-XXXX
  • Ankle replacement
    • Vantage® TAR Mobile-Bearing Polyethylene Liner Component
      • Vantage® Mobile-Bearing Polyethylene Liner Component
        • 350-41-XX
        • 350-42-XX
    • Vantage® TAR Fixed-Bearing Polyethylene Liner Component
      • Vantage® Fixed-Bearing Polyethylene Liner Component
        • 350-21-XX
        • 350-22-XX

What Are the Symptoms of Joint Replacement Failure?

The Exactech joint replacements were supposed to ease patient pain and enable them to use their joints smoothly. In many cases, the joint was replaced in the first place because the patient was experiencing limited mobility in that joint. The replacement joint was meant to restore that mobility so that the patient could live a normal life, at least for the life expectancy of the prosthetic. 

However, when the faulty liners and inserts were used in a joint replacement, the prosthetic failed much more quickly than expected. In some cases, the new joint never truly relieved the patient’s pain or improved their mobility. If a joint replacement fails, it can cause the following conditions:

  • Pain
  • Inflammation
  • Loosening
  • Infection
  • Dislocations

How Does Joint Replacement Failure Cause Pain?

Many of the different problems that can occur if a joint replacement prosthetic fails can cause pain. Typically, pain in the joint doesn’t occur alone if the joint replacement has failed. For example, if the joint replacement prosthetic has loosened, pain is a symptom of that. 

What Is Joint Replacement Inflammation?

Inflammation can occur if the body is trying to fight off something that it considers to be a foreign intruder. It’s a result of the body’s immune system working to deal with something that it considers an irritant. In a joint replacement, this can occur as a result of joint replacement failure, especially if the liner or insert degrades, which can cause particles of the plastic to enter the body.

What Is Joint Replacement Loosening?

Loosening is one of the more common ways in which a joint replacement prosthetic fails. Loosening is when the joint replacement prosthetic either isn’t firmly connected to the bone anymore or when the connection between different parts of the joint replacement prosthetic loosens where they connect to each other. Loosening does happen due to wear and tear over time, typically over a period of up to twenty years, although it can be shortened if the patient is overweight or engages in a lot of high-impact activities and exercise.

What Are the Symptoms of Joint Replacement Loosening?

If a patient is experiencing loosening in a joint replacement prosthetic, they may experience the following symptoms:

  • Pain
  • A popping sound
  • A clicking sound
  • Joint dislocation
  • Subluxation (partial joint dislocation)
  • A sensation that the joint is moving around
  • A feeling that the joint is giving out
  • Swelling

What Is Joint Replacement Infection?

An infection is a complication that can occur as a side effect of a joint replacement. Often, an infection can occur due to bacteria that can grow near or on the prosthetic. In some cases, an infection can happen shortly after the surgery occurred, but it can also happen later on, even years down the line. Degradation of components in the joint replacement could also contribute to an infection.

What Are the Symptoms of a Joint Replacement Infection?

If a patient gets an infection from the joint replacement, the symptoms to look out for can include the following:

  • Swelling
  • Redness
  • Pain
  • Drainage
  • Instability
  • Wounds that don’t heal

What Are the Symptoms of a Severe Joint Replacement Infection?

Infections can be very serious and require medical treatment in the emergency room. The symptoms of a severe infection can include all of the above, but also the following serious symptoms:

  • Fever
  • Nausea
  • Vomiting
  • Fatigue
  • Diarrhea

Anyone experiencing these symptoms should seek immediate medical attention. The minor symptoms of an infection should be presented to a doctor, but the symptoms of a serious infection warrant immediate medical consultation at the emergency room.

What Is a Joint Replacement Dislocation?

Another possible complication of a joint replacement is joint dislocation. Because a joint replacement prosthetic replaces a moving joint, there has to be a hinge of some kind that allows for movement while holding that joint together. For example, in a hip replacement, there’s a ball and socket joint. A dislocation occurs when the components of the prosthetic that connect to each other disconnect.

What Are the Symptoms of a Joint Replacement Dislocation?

If a joint replacement has become dislocated, a patient could experience some of the following symptoms:

  • Difficulty walking
  • Pain, especially around the affected joint
  • Weakness in the affected limb
  • Inability to move the affected joint
  • One leg is shorter than the other leg

What Is Revision Surgery?

Revision surgery is surgery performed to either repair or replace a joint replacement prosthesis. Anyone with a joint replacement should expect to need revision surgery at some point when the joint replacement prosthesis eventually fails. Typically, this is a decade or two away, unless the joint replacement or any of its components was faulty in some way, such as the Exactech joint replacement liners and inserts.

Is Revision Surgery Dangerous?

Any surgery has some amount of risk. These risks can include:

  • Bleeding
  • Blood clots
  • Reaction to the anesthetic
  • Infection
  • Scarring

The above risks are more likely to occur in revision surgery. For joint replacements in particular, revision surgery can be risky because, with each revision, the surgeon has to take away more of the original bone in order to attach the new joint replacement prosthesis. If a joint replacement fails early, this increases the risk of more than one revision surgery being necessary first to repair the faulty joint replacement and then again later for replacement as the prosthesis reaches the natural end of its lifespan and has to be replaced with a new one.

What Should You Do if Your Joint Replacement Was Recalled?

If you had a joint replacement surgery and the prosthesis failed early, causing you injury, pain, and/or requiring early revision surgery, the first step is to check that your joint replacement device was on Exactech’s list of recalled devices. Exactech offers a helpline ((888) 892-5635) for patients to call, but that number only offers pre-recorded messages with the answers to frequently asked questions.

How Can You Initiate a Claims Process with Exactech?

Exactech does also offer a phone number for initiating a claims process if your joint replacement was on the list. To initiate a claim, a patient would need the following information:

  • Name of surgeon
  • Date of surgery
  • Serial number of the joint replacement device

Once you have that information compiled, you can call (888) 912-0403 in order to begin the process of making a claim with Exactech.

What Does Exactech Pay for in a Claim?

If your claim with Exactech is successful, the company says that it will offer a reimbursement for the costs of the joint replacement. However, depending on the patient, there may have been more costs incurred, such as for the treatment of conditions resulting from the faulty device or revision surgery.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 


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