Since 2004, thousands of people in the U.S. suffering from knee and ankle pain have undergone surgery to implant Exactech replacement devices – only to experience more pain from their artificial implants. Many of those patients live in Greenville and across North Carolina.
What created the problem that led to a nationwide recall? Faulty packaging caused the devices to fail before they even entered the operating room.
Improper Packaging of Exactech Replacements
Exactech knee and ankle replacement systems marketed under the Optetrak, Optetrak Logic, and Truliant brands use plastic polyethylene inserts between metal components to cushion the joints. Tightly sealed vacuum bags enclose the Exactech devices for shipment.
By the company’s own admission, however, Exactech used “out-of-specification” or “nonconforming” vacuum bags, exposing the polyethylene inserts to high oxygen levels. Oxidation of the plastic inserts can cause the inserts to prematurely fail, degrade, break, or crack, necessitating revision surgery to correct the defect.
Patients with the failed devices have been plagued by pain and discomfort, inconvenienced by corrective surgeries and more rounds of physical therapy, and financially harmed due to increased medical expenses and further time off work.
Exactech Issues a Recall
Exactech started discreetly recalling the polyethylene liners in August 2021, followed by a widespread “URGENT MEDICAL DEVICE CORRECTION” in February 2022. The correction alerted physicians and hospitals of the recall and harmful defect. Exactech provided healthcare providers a draft letter to personalize and send to patients implanted with potentially degraded knee or ankle implants.
Signs and Symptoms of a Defective Exactech Device
If you were implanted with an Exactech knee or ankle replacement and suspect the plastic insert has failed, here are the signs and symptoms to watch for:
- New or worsening swelling.
- Pain while walking.
- Limited mobility.
- Inability to bear weight.
- Grinding, clicking, or other noise in the knee or ankle area.
- Bone loss requiring bone grafting.
- Debris collecting around the ankle or knee.
Holding Exactech Accountable for Your Injury
Data shows there were more revision surgeries involving Exactech knee and ankle implants than companies producing similar devices. With that information, Exactech knew or should have known the defective packaging posed risks to patient health and should have acted much earlier to address the problem and initiate the recall.
Rather than taking quick action, Exactech stayed silent for 17 years while surgeons implanted possibly faulty knee and ankle replacements in their patients. During those 17 years, affected patients suffered severe pain and injury before undergoing preventable revision procedures. Had Exactech scrutinized the product packaging, identified the problem, and ensured the plastic inserts would not degrade, these problems could have been avoided.
Patients should understand that Exactech, not their physicians, is accountable for the improper packaging, product failures, and resulting injuries. Unless your surgeon knew of the problem before your surgery and went forward with the implant surgery anyway, they are not liable for damages.
Contact an Attorney Experienced in Defective Medical Product Lawsuits
If you or someone you know received one of Exactech’s recalled knee or ankle replacements and has suffered any health issues associated with the insert and implant, you need a lawyer with experience handling defective medical device lawsuits – like the personal injury attorneys at Ricci Law Firm.
We know what it takes to go up against medical equipment manufacturers and their insurance companies. We know how to recover the damages you deserve, including:
- Pain and suffering.
- Anxiety and emotional distress.
- Cost of medical treatment and therapy.
- Lost income.
Pursuing compensation can be contentious and complicated, and the law gives you only a limited amount of time to bring your claim, so choosing the right firm to represent you may be the most important decision you make. Contact our Greenville office today for a free consultation about your situation.