Exactech, a prominent manufacturer of medical implants, is facing a new wave of legal problems after the FDA sent out a warning covering its Equinoxe Shoulder System joint replacement devices. Some of the implants may be defective due to packaging problems, potentially causing the implants to degrade and possibly leading to corrective surgery. This is not the first time Exactech has faced major problems with its implant devices, as it is facing 100s of lawsuits from patients who received knee, hip, and ankle implants.

• April 1, 2024 - FDA Warning: Exactech Shoulder Implants at Risk of Oxidation.
• March 1, 2024 - Exactech, a global company that specializes in orthopedic implants for joint replacements, has been forced to recall thousands of knee, hip, and ankle inserts after they have been found to be potentially defective.

Exactech, Inc., has faced numerous lawsuits for problematic joint implants over the last few years. However, while the root cause of defective packaging was the same, the previous lawsuits covered ankle, knee, and hip implants. In January 2024, the FDA delivered a new blow to the company, issuing a new warning that covers 17 years of its Equinoxe Shoulder System implants. We are at an early stage in the investigation, so we cannot say how many people have been impacted by faulty Exactech shoulder implants nor how many people will bring lawsuits against Exactech. However, the packaging defects cover almost two decades of implant procedures, so the number of people impacted could be considerable. Indeed, judging by the number of lawsuits covering other Exactech implant defects, the shoulder implant lawsuits could run into 100s, even 1000s, of claimants nationwide.

The FDA issued a warning covering Exactech’s Equinoxe Shoulder System implants in January 2024. The warning pointed to concerns over the safety of the shoulder joint implant due to defective packaging. In short, the packaging for some of the shoulder implants manufactured between 2004 and 2021 was missing an oxygen barrier layer, which protects the device from oxidation, a chemical process that can cause the plastic in the implant to degrade. The upshot is that some implants may break down quicker than expected, potentially requiring corrective surgery. The FDA is advising anyone with pain, swelling, or any other issues with their Exactech shoulder implant to contact their healthcare provider. In addition, it is advising healthcare providers to monitor anyone who has received an Equinoxe Shoulder System implant between 2004 and 2021.

Equinoxe Shoulder System is an implant treatment system from Exactech. It is not a specific device or treatment but rather a suite of tools for surgeons to perform shoulder arthroplasty (shoulder replacement surgery). The level of surgery may require the replacement of the entire joint or the replacement of a fractured humerus (hemiarthroplasty). Thus, it covers shoulder implant surgeries from the complex to the (relatively) straightforward.

Exactech markets its Equinoxe Shoulder System as being highly adaptable for surgeons to meet their patients' needs – what it terms “reversitility”.  One area it does that is via the conversion of the system into a reverse total shoulder arthroplasty, which is a specialized surgery to replace the damaged parts of the shoulder with artificial implants. The “reverse” part refers to how the shoulder is repaired and how your humerus and scapula work. In a nutshell, the humerus becomes the shoulder socket, and the scapula becomes the ball, reversing the norm. 

As with any personal injury lawsuit, payout awards for the Exactech defective shoulder implant lawsuits will depend on factors like the level of injury, cost of further surgeries, loss of earnings, medical bills, as well as more unquantifiable factors like mental anguish. We must wait for the extent of the problems with the Equinoxe Shoulder System to be clarified in the coming weeks and months to make a better estimate of how much claimants could receive.

As mentioned previously, we are at a very early stage in the Exactech shoulder implant lawsuits, so we cannot put a specific figure on what settlements for claimants might be worth, nor, indeed, do we know how the lawsuits will unfold. However, we can make some educated guesses due to the similarities with the Exactech knee, hip, and ankle lawsuits, which are at a more advanced stage. Some law firms are suggesting that claimants could receive payouts of anything between $50,000 and $300,000, although they maintain that this figure is a very rough estimate.

Anyone who has been injured by an Exactech shoulder implant treatment may be eligible to seek compensation against the company. Those who have already received treatment for a faulty implant, including corrective surgeries, are being urged to contact lawyers taking cases against Exactech. Anyone who has had the shoulder system treatment and is experiencing problems is being urged to contact their healthcare provider for more advice. If you require further treatment, then you may be able to claim to help with medical bills and other financial costs.

What are the lawsuits against Exactech?

Exactech is facing lawsuits after defective packaging for its Equinoxe Shoulder System has been flagged up by the FDA. The faulty packaging may cause artificial implants to rapidly degrade. Exactech is also facing numerous lawsuits for similar reasons from patients who have had ankle, hip, and knee system surgeries.

Is there a recall on shoulder replacement?

Not yet. The FDA has declined to issue a recall as of February 2024. However, it has urged healthcare providers to stop using shoulder implant devices contained within the faulty packaging, and it has advised anyone suffering from shoulder issues after having Equinoxe Shoulder System implants to contact their healthcare provider.

Who is the parent company of Exactech?

Founded in 1985, Exactech, Inc. is a private company headquartered in Gainesville, Florida. The company was previously a public company, but it was delisted from the NASDAQ in 2018 after a merger agreement with private equity firm, TPG Capital.

What are the symptoms of a failed shoulder replacement?

Symptoms of failed shoulder replacement could include swelling, pain, stiffness, popping and clicking sounds, and reduced motion. You should contact your healthcare provider if you have any of these symptoms after receiving an Exactech Equinoxe Shoulder System surgery.

What happens when a shoulder replacement goes bad?

Any number of things. You may require corrective surgery, a new implant, or other medical procedures. The specific issue with the Equinoxe Shoulder System seems to be that the implants degrade at a faster rate due to faulty packaging. This can lead to numerous problems, which may require surgery.