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Alonso Krangle, LLP Is Accepting Optetrak Knee Implant Claims

Exactech, Inc. recently issued a recall of every Optetrak knee replacement system made since 2004. Many of these devices have already been used to perform total knee replacements on patients.

The recall was because of a packaging problem that caused one of Optetrak’s components, the polyethylene insert, to degrade. The result of this defect in the Optetrak device is the premature failure of the knee implant system. Failure of the Optetrak knee replacement system requires patients to require revision surgery.

If you had knee replacement using the Optetrak device and suffered complications, including additional surgery, you might be entitled to file a lawsuit against Exactech. Call Alonso Krangle, LLP today to determine if you are eligible to file an Optetrak knee replacement lawsuit and collect compensation for your injuries.

Exactech Recall of Optetrak Knee Replacement Implants Leads to Lawsuits

Exactech, based in Florida, manufactures medical devices and has been doing so since the 1980s. Near the end of 2021, Exactech issued a worldwide recall of all of its Optetrak knee replacement implants made after 2004.

Defective packaging caused the polyethylene insert component to degrade, causing premature failure of the Optetrak knee replacement system.

Thousands of these recalled devices have already been used in knee replacement surgeries. Patients who required revision surgery because of the premature failure of the Optetrak are filing lawsuits against Exactech. The victims injured by the defective Optetrak device are seeking compensation for their injuries.

What Devices Are Included In The Recall of Optetrak Knee Replacement Systems?

Before exploring whether you are eligible to file an Optetrak knee replacement lawsuit, it is important to know what devices are part of the recall. The knee replacement parts were made between 2004 and 2022.

In February 2022, Exactech expanded the recall to include some ankle replacement devices. These items have all been packaged in “nonconforming” plastic bags that allow in oxygen, leading to faster degradation of the implants.

Here is a list of defective devices that are included in the Exactech recall according to the Exactech website at https://www.exac.com/wp-content/uploads/2022/02/Exactech-DHCP-letter.02.07.2022.pdf

Optetrak

  • All-polyethylene CR Tibial Components
  • All-polyethylene PS Tibial Components
  • CR Tibial Inserts
  • CR Slope Tibial Inserts
  • PS Tibial Inserts
  • HI-FLEX PS Tibial Inserts

Optetrak Logic

  • CR Tibial Inserts
  • CR Slope Tibial Inserts
  • CRC Tibial Inserts
  • PS Tibial Inserts
  • PSC Tibial Inserts
  • CC Tibial Inserts

Truliant

  • CR Tibial Inserts
  • CR Slope Tibial Inserts
  • CRC Tibial Inserts
  • PS Tibial Inserts
  • PSC Tibial Inserts
  • CC Tibial Inserts

Vantage

  • Fixed-Bearing Liner Component

This list was included in an Urgent Medical Device Correction letter sent by Exactech to surgeons in February 2022, warning them about defective packaging and potential dangers to patients who received these implants.

What Is The Specific Reason For The Optetrak Recall?

Exactech began the recall of Optetrak knee replacement systems when it discovered the packaging used for its devices since 2004 contained a serious defect.
The devices were packaged in “nonconforming, out-of-specification,” or defective bags. The polyethylene inserts, a crucial component of the Optetrak, Optetrak Logic, and other systems, were exposed to oxygen because of the defective packaging.

The vacuum bags used to protect the devices are oxygen resistant but do not contain a critical second layer of protection against air.

A second barrier containing ethylene vinyl alcohol (EVOH) is absent from these packages, which increases the likelihood of oxidation.

Because the implants are not packaged in an air-tight container, Oxygen exposure can cause the parts to degrade before they are even implanted in the body. Complications from and signs of premature degradation can include:

  • Accelerated wear and tear on the knee replacement system
  • Bone loss
  • Cracking
  • Immobility
  • Production of debris
  • Pain
  • Swelling

Patients who suffer early failure of the Optetrak knee replacement implant because of this defect will ultimately require revision surgery.

What Are Some Issues in Optetrak Knee Replacement Lawsuits?

All manufacturers have legal obligations.

They must ensure their products are reasonably safe when used properly and they don’t contain any design or manufacturing defects that can cause injuries. Manufacturers must also warn people about known risks associated with using their products. Manufacturers are responsible for acting reasonably to uncover risks and dangers they should know about.

Exactech has the same legal obligations – to ensure its surgical implants like Optetrak knee replacement inserts are safe and to warn about dangers.

With the recall, Exactech acknowledged that the implants are not safe – that they contain a manufacturing defect that can cause serious harm to patients.

Optetrak knee replacement lawsuits against Exactech will likely involve some of the following issues:

  • How long before the recall did Exactech know about the defective packaging?
  • Should Exactech have known about the defective inserts sooner?
  • Should Exactech have issued warnings about the likelihood of Optetrak failing?
  • Did Exactech know that Optetrak had a higher failure rate than other knee replacement implants? When did it know? Did Exactech notify anyone?
  • Were Optetrak implants designed defectively?
  • Was Exactech negligent?

Patients across the country are seeking evaluations of their Optetrak claims. Litigation is just beginning but is expected to increase as more patients realize that their injuries may have been avoidable.

What Compensation Is Available To People Injured By Defective Optetrak Implants?

There are no guarantees that anyone is entitled to compensation. However, in many product liability or defective medical device lawsuits, patients are awarded substantial damages for their injuries.

Compensation for injuries caused by the Optetrak knee replacement system might include:

  • Pain and suffering
  • Medical expenses, including the cost of revision surgery, medications, and physical therapy
  • Lost wages

Call us today to find out if you are should pursue an Optetrak knee replacement lawsuit and seek compensation from the manufacturer of this defective device.

Call Alonso Krangle, LLP For A Free Evaluation of Your Optetrak Knee Replacement Claim

Consider some questions:

  • Did your surgeon implant an Optetrak knee replacement insert that has been recalled?
  • Did you experience complications after your knee replacement?
  • Did your Optetrak knee replacement fail earlier than expected?
  • Did you require revision surgery? A new knee replacement?

If the answer to any of these questions is “yes,” call Alonso Krangle, LLP, at 800-403-6191 to schedule a free case evaluation. We want to hear your story and help determine if you have a claim against Exactech.

If you were the victim of a defective Optetrak knee replacement system, we can help you enforce your legal rights. Our goal is to ensure that victims of negligence receive the maximum compensation allowed by law. Call us today at 800-403-6191.

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