It is interesting how so many people carefully shop for an investigate their next appliance or television purchase, but how so few can tell you even the brand of hip or knee replacement that a surgeon placed inside their body. It is as though the brand of implantable device does not matter, and their seems to be an assumption that they are all the same.

A bad choice certainly has consequences, to the person who must undergo another painful surgery, and for the third party payor – such as a workers’ compensation claim administrator – who must pay tens of thousands of dollars in medical costs to remedy the situation.

The current litigation against Exactech is an excellent illustrative example. Exactech’s fortunes started to take off in 1994, when it inked a major deal to license and market the Optetrak knee implant based on designs by surgeons and engineers at the prestigious Hospital for Special Surgery in New York City. That alliance won Exactech instant credibility in the fiercely competitive device industry.

Exactech was first introduced in 2006. It is made of titanium and a plastic called polyethylene. The Optetrak implant was designed to be more durable and longer-lasting than other total knee replacement (TKR) implants. Building on that goodwill, Exactech’s sales shot past $124 million in 2007, about half generated by the Optetrak knee system.

The US Food and Drug Administration issued a number of safety warnings about the Optetrak implant. In 2012, the FDA issued a Class I recall of the Optetrak implant, which is the most serious type of recall. The recall was issued due to concerns about early failure of the implant.

In 2015, the FDA issued a Class II recall of the Optetrak implant due to concerns about loosening and osteolysis. The recall was issued after the FDA received reports of a number of patients who had experienced loosening and osteolysis of their Optetrak implants.

There are a number of class action lawsuits pending against the manufacturers of the Optetrak knee implant. These lawsuits allege that the implant is defective and has caused serious injuries to patients.The first class action lawsuit against the manufacturers of the Optetrak knee implant was filed in 2012. This lawsuit was filed on behalf of patients who had experienced early failure of their implants. Since then, a number of other class action lawsuits have been filed against the manufacturers of the Optetrak knee implant.

KFF Health News just featured a report on this problem, and what went wrong. It reports that there were ” years of warnings and doubts about the durability of the Optetrak, according to whistleblowers – one whistleblower called it an “open secret” inside the company. Notably, there were concerns about the fragility of a finned tibial tray, one of the four pieces of the knee replacement that fits into the shin bone, according to the whistleblower lawsuit.

Whistleblower Manuel Fuentes, a former Exactech senior product manager, testified in a deposition that pulling the product off the market around 2008 “would have been the ethical and moral thing to do.”

Exactech discussed the loosening problem in an internal memo that said between 2006 and 2009 the company “began to get some negative feedback” about the Optetrak “that was at times confounding and difficult to process,” court records show.The discouraging reports ranged from complaints of early revisions from at least 10 U.S. surgeons and surgery practices in several of the more than 30 countries where Exactech sold the implant, court records show.

The results did little to dim Exactech’s prospects. From 1994 through April 2022, Exactech sold 58,763 Optetrak devices with finned trays for use by 514 surgeons nationwide, according to an affidavit by a company official.

While 95% of artificial knees should last at least a decade, surgeons had to pull out and replace many Optetrak components – a complex operation known as revision surgery – much sooner, according to allegations in patient lawsuits.

The Food and Drug Administration runs a massive, public, searchable databank called MAUDE “Manufacturer and User Facility Device Experience” to warn the public of dangers linked to medical devices and drugs. This tool might be a good start for a due diligence investigation by a Claims Administrator to ascertain the track record of orthopedic devices.

Manufacturers must advise the FDA when they learn their device may have caused or contributed to a death or serious injury, or malfunctioned in a way that might recur and cause harm.Those reports must be submitted within 30 days unless a special exemption is granted.

But court and government records show that reports of adverse reactions tied to Exactech’s implant sometimes took years to show up in the government database — if they were reported at all.