Today, Exactech, a Gainesville, Florida medical device manufacturer, added 40,000 hip implants to its list of defective medical implant recalls. Exactech had already recalled over 90,000 hips,140,000 knees, and about 2,500 ankles. All of the recalls related to a failure of the polyethylene parts in the implants. The failure of the polyethylene generally results in the need for surgery to remove the implant and replace it with a different type of implant.
Doctors generally expect a knee of hip implant to last for 20-40 years or possibly a lifetime before wearing out. The Exactech polyethylene is wearing out sometimes in 2 or 3 years. The plastic debris from the poly wear causes an adverse reaction in an implant patients bone called osteolysis. This osteolysis causes the bone to deteriorate making revision surgery and rehabilitation more difficult. It also 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 cited the causes as surgeon technique or patient specific factors. As a trial lawyer involved in litigating these cases, I have suspected that there was a defect in the process that Exactech was using to manufacture its poly. The new recall makes some admissions that, in fact, there is a problem with the design of the poly. The August 11, 2022 recall letter to surgeons and hospitals admitted that:
“Our analysis shows that this moderately cross linked material, which is unique to the GXL liner, in inherently more susceptible to oxidation and polyethylene wear in the hip versus modern, highly crosslinked Vitamin E polyethylene liners.”
In the Exactech knee recall of October 4, 2021, the company blamed failure of knee polyethylene on non conforming plastic packaging that allowed oxygen to be exposed to the devices during shipment and storage. Now, Exactech has added the packaging issue to the description of the causes of the hip failures for the first time.
The hip models included in the new recall include the Acumatch GXL, Novation GXL, MCS GXL, Exactech All Polyethylene Cemented Cup, Acumatch Conventional UHMWPE, MCS Conventional UHMWPE, and Novation Conventional UHMWPE.
There are fewer than 100 cases filed in state and federal courts in the U.S. that have been brought by patients who have had implant removed. There are about 40 cases filed in Florida state court in Gainesville, Florida where the company is located and about an equal number in federal courts around the U.S. There is a hearing at the end of August, 2022 in the Florida court to coordinate the discovery and progress of the cases before one judge. In the federal courts there is a petition to coordinate the cases together in a multi district litigation for pretrial discovery. These are all individual cases not a class action. That motion for federal coordination will be heard at the end of September 2022.
None of the Exactech cases have gone to jury trial and I do not believe that there have been any settlements.
There is also a whistleblower case that is proceeding alleging that Exactech choose not to report its early failures to the U.S. Food and Drug Administration, the FDA, 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 because of 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 or stating the the implant failures were due to surgeon error.
If you or a loved one has an Exactech hip, knee, ankle, or shoulder implant call for a free consultation at 800-748-7115.
Admitted to practice law in all federal multidistrict litigation courts, the California State Bar and the Florida Bar. His philosophy is to provide aggressive, quality representations and seek fair compensation for individuals and their families who have suffered injury, death, or sexual abuse.
Comments for this article are closed.