Exatech Inc. has expanded its hip recall to include another 40,000 components that may be defective following an earlier recall of nearly 250,000 knee, hip, and ankle replacements over the past year because of problems with polyethylene liners. These recalls have led to multiple lawsuits over the defective devices as patients find themselves facing the possibility of revision surgery, additional rehabilitation and permanent disability.
The company sent a letter to medical practitioners in August expanding the hip implant recall involving acetabular hip liners used in its Connexion, GXL, Acumatch, MCS, and Novation systems.
What Medical Implants Has Exactech Recalled?
Exactech had already recalled over 90,000 hips,140,000 knees, and about 2,500 ankles due to a failure of the polyethylene parts in the implants. That failure may require surgery to remove the implant and replace it with a different type of implant.
Surgeons expect a knee or hip implant to last for 20 years or more before wearing out. But the Exactech polyethylene is wearing out after as few as two or three years in some cases. Plastic debris can cause an adverse reaction in an implant patient’s joint, and lead to bone loss called osteolysis. Osteolysis makes revision surgery and rehabilitation more difficult, and can leave a patient with a permanent disability.
In the first Exactech hip recall on June 28, 2021, the company reported a high failure rate but blamed surgeon technique or patient-specific factors. However, the new recall does reference a problem with the design of the polyethylene.
“Our analysis shows that this moderately cross-linked material, which is unique to the GXL liner, is inherently more susceptible to oxidation and polyethylene wear in the hip versus modern, highly crosslinked Vitamin E polyethylene liners,” Exactech’s letter said.
Exactech is urging surgeons to follow up with patients who received a GXL liner in the past 12 months. Surgeons are also urged to follow up with patients who received conventional liners that were packaged in nonconforming packaging that has not been examined in the past 12 months.
The company is not recommending the removal of recalled hip replacements that are functioning and are not causing pain.
Why is Exactech Being Sued?
Exactech is already facing multiple lawsuits in various fronts, including by patients who were forced to have implants removed as well as suits filed by whistleblowers.
The U.S. Judicial Panel on Multidistrict Litigation (JPML) recently centralized and consolidated all Exactech knee replacement and hip replacement lawsuits that have been filed in the federal court system The federal lawsuits are now being consolidated and transferred to the Federal District Court for the Eastern District of New York.
There are about 75 cases filed in a Florida state court in Gainesville, where the company is located, and roughly another 80 or more pending in federal court. There is also a whistleblower case alleging that Exactech chose not to report its early failures to the U.S. Food and Drug Administration as required by law. This lawsuit seeks to recover expenses paid by the Veterans Administration and Medicare to purchase the devices that failed to comply with federal law due to the reporting violations.
Additionally, there is a defamation case against Exactech brought by a doctor in Birmingham, Alabama, for defamation and damage to his medical practice for implying that the implant failures were due to surgeon error.
Also, three whistleblowers can advance claims that Exactech violated the False Claims Act by providing defective knee replacement devices to Medicare, Medicaid, and Department of Veterans Affairs beneficiaries, an Alabama federal district court ruled.
The Court found that the whistleblowers adequately alleged that Exactech sought reimbursement from the government for devices that weren’t medically reasonable and necessary. The Court also held that the plaintiffs adequately alleged that Exactech failed to tell the government about numerous revision surgeries involving the devices.
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