Exactech Recall Letters May Never Reach Some Knee, Ankle Replacement Recipients

After a massive Exactech recall was issued earlier this year, impacting ankle and knee replacements widely used since 2004 that may be prone to fail prematurely, surgeons were told to send recall notices to former patients about the risks. However, tens of thousands of individuals who received the recalled implants still haven’t received any notification, and it appears that many never will.

Exactech first announced the ankle and knee replacement recall in February 2022, posting information on their website and notifying surgeons who implanted the defective components. The manufacturer provided surgeons with sample Exactech recall letters (PDF) that could be sent to patients, but no system was established to make sure the notifications actually reached patients, many of whom have moved or already had the defective implant replaced years ago.

The recall impacts 60,926 Exactech Optetrak knee implants used since 2004; 60,518 Exactech Optetrak Logic knee implants used since 2009; 24,727 Exactech Truliant knee implants used since 2017; and 1,561 Exactech Vantage ankle replacement systems used since 2016. Each of these joint replacement systems contained a polyethylene insert that was packaged in a defective vacuum bag, which allowed oxygen to diffuse the plastic component before it was implanted.

The manufacturer now acknowledges that this oxidation causes a substantial risk of premature failure, including accelerated wear, debris production, bone loss, cracking, fracture or component fatigue, all of which may result in the need for additional revision surgery within a few years.

As a result of the problems, a growing number of former users are already pursuing an Exactech knee lawsuit against the manufacturer, with many indicating that they did not learn about the problems until they saw attorney advertisements regarding the recall.

Rather than taking independent actions to make sure all individuals are notified about the recall, Exactech has relied on surgeons to notify their former patients.

“[I]f you have been experiencing any new or worsening knee swelling, pain while walking, inability to bear weight, grinding or other noise, instability, or any new symptoms of clicking in your knee, please call our office to schedule an evaluation,” according to the proposed Exactech recall letter drafted by the manufacturer. “At this time, if your knee is functioning well and you have no pain and no symptoms, revision surgery is not recommended.”

In the recall statement, the manufacturer acknowledged that Exactech knee failures have been reported by users for years, which appear to be related to the defective inserts, and many of these recalled implants failed years ago. However, it does not appear that any attempts are being made to notify former patients who already had the defective removed from their body.

The sample letter provided to surgeons indicates that Exactech is offering to assist patients with certain out-of-pocket costs linked to clinical follow-up or if any additional or revision surgeries are necessary. However, no reimbursement has been offered to individuals who have already gone through the pain and inconvenience of revision surgery after their knee failed. In addition, no details have been provided about what compensation the manufacturer may provide, and knee replacement attorneys are urging all individuals who received these recalled components to seek legal representation before contacting the manufacturer directly.