Implantation of a defective medical device can cause a wide range of issues, and necessitate the significant pain and inconvenience associated with revision surgery and recovery.
In the case of Exactech Inc. the company has recalled hundreds of thousands of partial and complete hip, knee and ankle joints manufactured and implanted in the United States over the last 20 years. The defect is a result of faulty packages of plastic parts, which can prematurely wear or degrade in the body. The parts were meant to replace cartilage, absorb some of the pressure and friction within the joint, and facilitate movement.
In issuing the recall, Exactech Inc. stated a “Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.”
The company reports defective packaging may allow oxygen and other environmental contamination to degrade the plastic. If you have received notice from the company of your physician, contact us for a confidential consultation with our defective medical device attorneys in Colorado to determine the best course of action to protect your rights.
Common consequences of dealing with these defective Exactech implants include:
- Pain: Joint-replacement surgery is a painful procedure that is often accompanied by a substantial and trying period of recovery. But when an implanted joint fails as a result of a defect or improper implantation, additional pain and discomfort may exceed the pain and discomfort that prompted the patient to undergo the initial joint replacement. Revision surgery may be more difficult, particularly if bone-wear, fitment or infection further complicate repair.
- Stiffness: The improperly packaged plastic component is designed to act as a replacement for cartilage to assist with comfort, movement and shock absorption. Exactech reports degrading of the component can result in “reduction of mechanical properties” of the joint. To the patient, that means pain and loss of movement.
- Limited mobility: Most people pursue joint replacement because a bad joint is causing them pain and impacting their mobility and quality of life. The artificial joint is aimed at improving mobility and independence. However, there is often a substantial recovery period. When a joint proves defective, a patient can often find themselves in a worse position than before surgery. The need for a revision surgery can result in lasting consequences, particularly for older patients.
- Loosening: Historically, many defective artificial joints resulted in loosening, bone degeneration, and metal shavings that resulted from degrading device components. New generation polymers aimed to solve some of those issues but are often experiencing shortened longevity, and other issues, as we see with the Exactech hip, knee and ankle components. Loosening can cause a wide range of issues, including stiffness, loss of range of motion, instability, bone wear, pain and joint failure.
- Osteolysis: Disappearance or wearing of bone. This is the most serious problem limiting the longevity of artificial joints. It is caused by bone-resorptive responses to wear particles originating from the articulating surface. Advanced plastics and polymers were supposed to help solve this problem. However, we are now seeing failures of defective medical products related to such plastic components. Such failure can result in Osteolysis, which in addition to significant loosening and discomfort, can complicate fitment, repair, and replacement during revision surgery.
As part of the recall of its defective hips, knees, and ankles, Exactech Inc. has hired a third party administrator to determine eligibility for those who might qualify for reimbursement of “out-of-pocket” expenses associated with the company’s attempts to fix its defective products. As part of the process, the company will require you to undergo a medical examination, which may also be used to defend itself against any future claims. If you are suffering from surgical complications or issues related to a defective hip implant, please call the defective medical product attorneys at the McLaughlin Law Firm at (720) 463-1516 for a free and confidential consultation to discuss your rights.