Exactech Inc. has expanded its extensive recall of its artificial hip and knee joints to include its artificial ankle joints manufactured and implanted in the United States since 2016.
The ankle joint under recall is the VANTAGE® Fixed-Bearing Liner Component.
For more than 20 years, Exactech Inc. used defective packaging across a wide–range of its artificial joint products and has already recalled hundreds of thousands of artificial knee and hip joints manufactured and implanted since 2004.
A critical component, a plastic inserts meant to facilitate fitment and movement as well as increase comfort and protect bone and surrounding tissue from the consequences of metal components rubbing together, was packaged in vacuum bags that did not contain an additional oxygen barrier layer of Ethylene Vinyl Alcohol (EVOH). This can allow increased oxidation of the plastic, leading to a reduction of mechanical properties of the knee joint, premature wear and joint, bone and tissue damage.
“After extensive testing, we have confirmed that most of our total knee replacements (TKR), partial knee replacements, (PKR), and total ankle replacements (TARs) with polyethylene (plastic) components and inserts manufactured since 2004 were packaged in out-of-specification (referred to hereafter as “non-conforming”) vacuum bags,” the company said in a letter to surgeons and patients.
Consequences of Defective Exactech Ankle Joints
The company acknowledged the following risks:
- Statistically significant and higher than expected early revision rates.
- Increased plastic wear.
- Potential development of osteolysis (bone loss).
- Up to a 700 percent increase in the potential for pain and joint loosening.
- Potential for device loosening, device fracture, pain, bone loss and recurrent swelling.
Patient Rights after Implantation of Defective Joints
The company has hired a third-party administrator to review claims for potential payment of out-of-pocket expenses associated with revision surgery and other medical procedures that will attempt to fix its defective joint. Exactech will require patients to undergo a medical examination, which it will use to determine eligibility or denial, and which it may use to later defend itself against a claim.
Our defective medical device attorneys in Colorado urge anyone dealing with issues related to joint replacement surgery to contact an experienced law firm. The reality is that many of these joints have proven defective over the years. This new generation of polymer lined joints was designed after first-generation metal-on-metal joints resulted in a host of issues, ranging from bone loss, to infections caused by metal shavings in surrounding tissue.
Patients undergo joint replacement in an effort to improve mobility and quality of life. These surgeries are expensive, painful, and often necessitate a lengthy recovery process. Complications that result in the need for revision surgeries may result in a more difficult recovery and more uncertain outcomes, particularly for older patients. A failed joint may also have damaged other components or surrounding bone and tissue.
Additionally, allowing Exactech to minimize its costs by paying patients the bare minimum while attempting to repair a faulty joint may not be in the patient’s best interest. An experienced defective medical device attorney in Colorado will be in the best position to determine all of the compensation to which you are entitled and can help you determine the best medical solution for your situation. If you are suffering from surgical complications or issues related to a defective ankle implant, please call the McLaughlin Law Firm at (720) 463-1516 for a free and confidential consultation to discuss your rights.