Exactech Hip, Knee and Ankle Recalls

Exactech is a medical device company that creates implants, instruments, and technologies for joint replacements. After considerable research, Exactech confirmed that most of its total knee replacements, partial knee replacements, and total ankle replacements with polyethylene components and inserts were packaged in non-conforming vacuum bags which have been associated with various risks. The vacuum bags are oxygen resistant, however, do not contain a second layer of ethylene vinyl alcohol which further supplements the oxygen resistance. The implants manufactured by Exactech and packaged in non-conforming bags have been associated with: (1) higher and earlier than expected revision rates, (2) increased risk in polyethylene wear, and (3) development of osteolysis, bone loss.

When you go to see your doctor and agree to a joint replacement, you assume you’ll be implanted with a safe product, but unfortunately, some of these implants are defective and do significant harm to patients that necessitates further surgical procedures. It may be appropriate for harmed patients to pursue damages in a product liability lawsuit. If you were harmed by a defective knee replacement, you should talk to the seasoned product liability lawyers of Moll Law Group. We represent clients around the country. Billions have been recovered in cases with which we’ve been involved.

On June 28, 2021, Exactech recalled its Connexion GXL acetabular liners. Over the past 24 months, Exactech observed the Connexion liners showing early linear and volumetric wear. This wear was found to lead to proximal femoral and acetabular osteolysis. Exactech has recommend individuals who are less than six years from their initial replacement surgery and who have not been seen in over 12 months to return to an office for a routine clinic exam and x-ray.

This hip replacement recall is a class 2 recall, which involves temporary or medically reversible problems. As a patient who has this implant, you could face accelerated wear, bone loss, component fatigue, component fracture or cracking, and debris production that need revision surgery, and should be on the lookout for pain and talk to your health care provider about your implant.

When knee and ankle replacements are defective and fail, patients may need to undergo one or more revisions surgeries to have the implant replaced. As a patient, you may need to take time off work, you may be left disabled, and you may suffer pain after being implanted with a defective product. The manufacturer responsible for making a defective product, and others in the stream of commerce should be held accountable.

On August 31, 2021, Exactech recalled its polyethylene plastic inserts, “Ultra-High Molecular Weight Polyethylene,” used as part of both knee and ankle replacements. They fit between metal components in a replacement to cushion a patient’s joint. The reason for the recall is that the plastic in them could wear out early, thereby causing the implant to fail so that revision surgery is needed. The recall impacts tibial inserts and liner components from the Vantage, Trulian, Optetrak Logic, and Optetrak knee and ankle replacement systems.

The out-of-specification packaging didn’t properly protect the inserts from oxygen exposure, according to the company’s Urgent Medical Device Correction letter sent to surgeons in February 2022. When exposed to oxygen, the inserts can degrade over time, resulting in early device failure. All knee and ankle inserts, regardless of their label or shelf-life, are recalled if they were packaged in out-of-specification packaging. Exactech confirmed that the inserts made since 2004 were so packaged, and that around 147,732 devices have been implanted since that time. The Optetrak Knee system has been sold since 1992 and results in notably higher revision rates.

The recall is a class 2 recall, which involves temporary or medically reversible problems. As a patient who has this implant, you could face accelerated wear, bone loss, component fatigue, component fracture or cracking, and debris production that need revision surgery, and should be on the lookout for pain and talk to your health care provider about your implant.

When a patient is implanted with a defective joint replacement, he or she may suffer significant pain and face the costs of a revision surgery, which can be considerable. These expenses and losses may be recoverable in a product liability lawsuit. These are lawsuits brought when a product is defective in terms of its design, manufacturing, or marketing. Since multiple systems and devices are affected, our lawyers would likely investigate the possibility of a design defect, which is a flaw in the specifications for the product. When a manufacturer becomes aware of a defect, it should provide adequate warnings.

When we can establish liability, we may be able to recover compensatory damages, which are damages intended to put consumers back in the position they would have been in had they not been implanted with a defective device. However, plaintiffs have alleged in connection with joint implants that the manufacturer knew about the early failures and yet failed to warn consumers and kept selling defective devices. When a manufacturer knows about defects and fails to act to protect consumers, it may be appropriate to pursue punitive damages, which are intended not only to make a consumer whole, but also punish and deter manufacturer wrongdoing.

If you were harmed by a defective joint replacement, whether Exactech or other type, you should talk to the experienced product liability lawyers of Moll Law Group about your situation. We represent clients across the country who were injured by defective products. Please complete our online form or give us a call at 312.462.1700.