Exactech Implant Recall Leads to Lawsuits Over Premature Failures
Exactech, a Florida-based medical device company, is facing mounting lawsuits from patients who claim that the company’s knee and hip implants failed prematurely, necessitating painful and risky revision surgeries. The lawsuits allege that Exactech downplayed or concealed evidence of product failures from patients and regulators for years, prioritizing profits over patient well-being. More than 1,100 patients are seeking justice after Exactech began recalling artificial knees, hips, and ankles in August 2021, citing a packaging defect that could cause premature wear in about 140,000 implants.
5 Key Points
- Exactech, a Florida-based medical device company, is facing a wave of lawsuits from patients alleging that its knee and hip implants failed prematurely.
- The lawsuits accuse Exactech of downplaying or concealing evidence of product failures from patients and regulators for years, prioritizing profits over patient safety.
- Whistleblowers allege that Exactech knew about problems with its Optetrak knee implant for years but failed to take appropriate action, engaging in a “silent recall” instead.
- Court and government records show that Exactech sometimes took years to report adverse events related to its implants to the FDA’s MAUDE database, if they were reported at all.
- In August 2021, Exactech initiated a recall of its knee, hip, and ankle implants, citing a packaging defect that could lead to premature wear, but for many patients, the recall came too late, and they had already undergone painful revision surgeries.
The Rise of Exactech in the Medical Device Industry
Exactech was founded in 1985 by orthopedic surgeon William “Bill” Petty, his wife Betty, and biomedical engineer Gary Miller. The company started as a small, family-run business but quickly grew into a global entity, thanks in part to its licensing of the Optetrak knee implant in 1994. This deal instantly boosted Exactech’s credibility and revenue in the fiercely competitive medical device industry. By 2007, the company’s sales had surpassed $124 million, with the Optetrak knee system accounting for about half of that amount. In 2018, Exactech was acquired by private equity firm TPG Capital for $737 million.
Early Warnings and Complaints About Optetrak Implants
Despite Exactech’s rapid growth and success, the company faced years of warnings and doubts about the durability of its Optetrak knee implant. Several surgeons reported that the implants were loosening prematurely, causing significant pain and limiting patients’ ability to move around. In some cases, revision surgeries were required in as little as two to three years after the initial implantation – a timeframe considered “awfully premature” by industry standards. One surgeon, Dr. Christopher Hutchins, reported that he had to remove and replace Optetrak components much sooner than expected in many of his patients. He raised his concerns directly with Exactech co-founder Bill Petty, who allegedly acknowledged the problem but failed to take adequate action.
Whistleblowers Allege Coverup of Product Failures
Whistleblowers who worked for Exactech have come forward, alleging that the company knew about problems with the Optetrak knee implant for years but failed to take appropriate action. According to one whistleblower lawsuit, Exactech executives discussed the idea of a recall as early as 2008 but ultimately decided against it, deeming it “financially detrimental.” Instead, the company allegedly engaged in a “silent recall” by replacing the problematic component in newer versions of the Optetrak without properly notifying patients or regulators.
Failure to Properly Report Adverse Events to FDA
Court and government records reveal that Exactech sometimes took years to report adverse events related to its implants to the FDA’s MAUDE database, if they were reported at all. The company is accused of failing to conduct adequate investigations into complaints and blaming surgeons for poor outcomes rather than acknowledging potential defects in its products. FDA inspectors who examined Exactech’s internal files in 2017 cited the company for not undertaking an “adequate investigation” of complaints.
Promoting Products Despite Growing Concerns
Even as evidence of problems with the Optetrak knee implant mounted, Exactech continued to promote the product, highlighting “excellent results” achieved by certain surgeons. However, the company allegedly ignored or discredited negative reports from other countries, where high revision rates were observed. Exactech also paid substantial consulting fees – totaling more than $23 million from 2013 to 2022 – to some orthopedists who used or promoted the company’s implants. Critics argue that Exactech had an obligation to inform surgeons about the poor outcomes observed overseas rather than selectively touting positive results from doctors on its payroll.
The Recall and Its Impact on Patients
In August 2021, Exactech finally initiated a recall of its knee, hip, and ankle implants, citing a packaging defect that could lead to premature wear. For many patients, however, the recall came too late. They had already undergone difficult and painful revision surgeries to replace failed implants, often experiencing reduced mobility and quality of life as a result. Some patients, like Laura Grandis of Ohio, endured multiple revision surgeries and prolonged recovery periods after their Exactech implants failed much sooner than expected.
Lawsuits Demand Accountability from Exactech and Its Owners
As a result of the recall and the alleged coverup of product failures, Exactech now faces a flood of lawsuits from patients seeking accountability for their injuries. Most of the suits name not only Exactech but also its past and present owners, including Bill, Betty, and David Petty, Gary Miller, and private equity firm TPG Capital. The lawsuits accuse the defendants of prioritizing profits over patient safety and failing to take timely action to address known defects in the company’s implants. Exactech maintains that its products are not defective and that factors such as patient size, activity level, and surgical technique may contribute to implant failures.
Exactech Recall FAQ
What specific Exactech products are affected by the recall?
The recall includes Exactech’s knee, hip, and ankle implants, particularly the Optetrak knee system.
How can patients find out if their implant is part of the recall?
Patients should contact their orthopedic surgeon or the hospital where their surgery was performed to determine if their implant is affected by the recall.
What steps should patients with Exactech implants take?
Patients with Exactech implants should consult their orthopedic surgeon for an evaluation, even if they are not currently experiencing any symptoms or problems.
What is the typical expected lifespan of a knee or hip implant?
Knee and hip implants typically last 15 to 20 years, depending on factors such as the patient’s age, weight, and activity level.
What are the risks and challenges associated with revision surgery?
Revision surgery is often more complex and carries higher risks than the initial implant surgery, including increased pain, longer recovery time, and potential complications such as infection or nerve damage.
Citations:
- Schulte, F. (2023, October 10). Thousands Got Exactech Knee or Hip Replacements. Then, Patients Say, the Parts Began to Fail. KFF Health News. https://kffhealthnews.org/news/article/exactech-hip-knee-replacement-implant-lawsuit/
- United States District Court, Northern District of Alabama. (2018). United States of America et al v. Exactech, Inc. Case 2:18-cv-01010-LSC.
- Food and Drug Administration. (2022). Manufacturer and User Facility Device Experience (MAUDE) Database. https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfmaude/search.cfm
- Centers for Medicare & Medicaid Services. (2023). Open Payments Data. https://openpaymentsdata.cms.gov/
