Exactech’s Defective Polyethylene Plastic Inserts
Exactech, a global medical device manufacturer of surgical implants used in joint replacement surgeries, has confirmed that most of the plastic polyethylene inserts manufactured since 2004 were packaged in out-of-specification (or non-conforming) vacuum bags that are oxygen resistant but do not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.
The use of these non-conforming bags may enable oxygen to reach the plastic inserts before they are implanted, causing the component to oxidize and wear out much earlier than expected or become damaged after being implanted in the body.
The polyethylene plastic insert serves a critical function throughout the life of the replacement system. The plastic insert is a “shock absorber” and replaces the function of cartilage in your knee joint. If this insert fails, the knee replacement fails.
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Complications & Symptoms
The degrading of the polyethylene plastic insert can cause it to fracture or crack after a relatively short period leading to early failure of the implant system. Premature wear of a polyethylene plastic insert can cause serious damage and result in the need for a corrective revision surgery.
- Accelerated knee wear
- Bone loss
- Debris production
- Component cracking, fracture, or fatigue
- Knee revision surgery
Symptoms patients may experience include:
- Severe pain, new or worsening
- Pain walking
- Inability to bear weight on the joint
- Grinding noise in the joint
- Instability in the knee or ankle
Exactech Knee Recall
In August 2021, Exactech first issued a recall of its knee arthroplasty polyethylene inserts packaged in non-conforming bags limiting it to only those products with a remaining shelf life of five years or greater as of August 31, 2022. However, as of February 7, 2022, that recall has been expanded to include ALL knee and ankle polyethylene inserts packaged in non-conforming bags regardless of label or shelf life, including:
- OPTETRAK® – 60,926 implants since 2004
- OPTETRAK Logic® – 60,518 implants since 2009
- TRULIANT® – 24,727 implants since 2017
- VANTAGE® – 1,561 implants since 2016
Product Specific Information and Recall Notice, dated February 7, 2022
According to Exactech’s Frequently Asked Questions document, the company has confirmed that most of their total knee replacements (TKR) and total ankle replacements (TAR) with polyethylene (plastic) components and inserts manufactured since 2004 were packaged in non-conforming vacuum bags that are oxygen resistant.
The FDA has classified this field action as a Class II recall. This means that exposure to the product may cause temporary or medically reversible health consequences or where the probability of serious health consequences is remote.
This recall affects more than 140,000 Exactech knee replacement systems implanted in the United States since 2004 and hundreds of Exactech ankle replacements.
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Exactech Knee Problems Before Recall
Over the years, Exactech has been subject to a number of knee lawsuits filed over alleged design defects. In 2017, Exactech faced lawsuits involving abnormally high failure rates associated with its OPTETRAK knee replacement system. These lawsuits indicated that an alarming rate of adverse event reports was being submitted to the FDA.
The Exactech OPTETRAK knee replacement system was introduced through the FDA’s controversial 510(k) fast-track approval process. This means that the manufacturer (Exactech) did not have to undergo extensive testing for safety and effectiveness. They only needed to show that the device was “substantially equivalent” to existing devices.
More Product Recall Concerns for Exactech
After a number of adverse event reports indicated premature device failure, in June 2021, Exactech’s Connexion GXL acetabular polyethylene liners were recalled by the FDA. The recall stated patients who received these implants had an increased risk for premature wear and edge-loading of components that can lead to device loosening and lack of mobility, severe pain, and osteolysis or death of bone tissue.
Read: Exactech Lawsuit Filed in Florida Court Against Hip Manufacturer Over Recalled Connexion GXL Hip Liner Implant
More than 90,000 hip replacements with the Exactech Connexion GXL liners were recalled in 2021. Lawsuits are now being filed against the company and are expected to grow significantly.
How Can you Obtain financial compensation?
Companies like Exactech that manufacture medical products have a responsibility to make their products reasonably safe in their design, manufacture, and packaging and should be held responsible when there is a problem.
Patients face an increased risk of knee or ankle replacement failure, complications caused by the defective plastic insert along with unnecessary medical bills, and pain and suffering.
While Exactech has a claims process to reimburse you for your out-of-pocket expenses related to the defective implant, we recommend you talk with one of our experienced product liability attorneys first. Should you decide to file a claim through Exactech’s process you may be waiving your right to file a product liability claim against the company. Let us help you understand your legal rights.
Find out if you have a case against Exactech.
Complete our Case Evaluation form.
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FREE CASE EVALUATION FROM DEDICATED, EXPERIENCED ATTORNEYS
It can be devastating when the medical devices you rely on fail. The Nash & Franciskato Law Firm has a proven track record against medical device manufacturers.
What we offer goes beyond experience. Our legal team is dedicated to you and helping you put your life back together, giving you:
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START YOUR FREE, CONFIDENTIAL EVALUATION WITH ONE OF OUR TEAM
If your Exactech knee or ankle replacement implant failed and you have been advised to undergo a revision surgery, or have already had one, contact Nash & Franciskato at (877) 284-6600. The time to request your free, no-obligation case review is today. We will review your case in a free and confidential consultation, with no risk or obligation to take legal action.