Exactech Knee Recall Lawsuit - Top 9 Questions Answered

An Exactech lawsuit is a claim against the medical device manufacturer for selling defective joint implants, requiring patients to undergo additional surgeries.

Shouse Law Group is pursuing the highest monetary settlement available under the law for Exactech victims throughout the United States. In order to be eligible for a lawsuit, you must:

have been implanted with a recalled Exactech knee, hip, or ankle device; and
have undergone – or will undergo – a revision surgery to replace or repair the defective implant.

In this article, our Exactech implant lawsuit attorneys discuss:

1. What Exactech implants have been recalled?

Over the course of 2021 and 2022, Exactech has recalled the following knee, ankle, and hip arthroplasty implants:

Recalled Exactech ankle and knee implants

ARTHROFOCUS® Polyethylene Tibial Inserts (TKR)
OPTETRAK® All-polyethylene Tibial Components (PKR)
OPTETRAK® All-polyethylene Tibial Components (TKR)
OPTETRAK® Custom Polyethylene Tibial Inserts (TKR)
OPTETRAK® HI-FLEX® Polyethylene Tibial Inserts (TKR)
OPTETRAK® Tibial Inserts (TKR)
OPTETRAK® LOGIC® Polyethylene Tibial Inserts (TKR)
OPTETRAK® Logic RBK Tibial Components (TKR)
OPTETRAK® RBK® Polyethylene Tibial Inserts (TKR)
TRULIANT® Tibial Inserts (TKR)
Vantage® Fixed-Bearing Polyethylene Liner Component (TAR)
Vantage® Mobile-Bearing Polyethylene Liner Component (TAR)

Recalled Exactech hip implants

Acumatch Conventional UHMWPE
Acumatch GXL Acetabular Liners
Exactech All Polyethylene Cemented Acetabular Cup
MCS Conventional UHMWPE
MCS GXL Acetabular Liners
Novation GXL Acetabular Liners

The recall covers all the above-listed devices manufactured from January of 2004 to January of 2022.¹

Joint replacement implants consist of metal pieces joined by a plastic insert that acts as cartilage.

2. Why were they recalled?

The recalled Exactech inserts were manufactured in vacuum bags that lacked an ethylene vinyl alcohol (EVOH) barrier layer to augment oxygen resistance. This increased oxygen diffusion can degrade the inserts’ UHMWPE (ultra-high molecular weight polyethylene) material. As a result, patients with these recalled inserts may experience:

accelerated wear debris production,
bone loss, and/or
cracking of the insert.

In short, increased oxidation of the inserts’ mechanical properties may result in the patient requiring corrective revision surgery.

This recall of Exactech’s knee and ankle arthroplasty polyethylene inserts has been classified as a class II recall by the FDA. This means that patients implanted with these inserts may experience temporary or medically reversible health consequences.²

3. How do I know if I have a recalled implant?

Your healthcare provider should have sent you a letter notifying you of the Exactech recall. The name of your implant device should also be in your medical records.

If you know your implant’s serial number, you can check to see if it has been recalled by entering it on the Exactech website here.

If you are unsure whether your ankle, knee, or hip implant has been recalled, contact your doctor.³

4. Do I need a revision surgery?

Contact your physician to discuss whether you need a revision surgery to replace your Exactech implant. Your doctor should order X-rays to help make an evaluation of your next steps.

In the meantime, document whether you are experiencing:

new or unusual pain or discomfort,
an inability to bear weight,
unusual noises, such as grinding,
swelling,
instability, and/or
mobility difficulties.

For as long as you are feeling well and your Exactech implant shows no signs of failure, then a revision surgery is not recommended.⁴

5. What money can I get if I sue?

Our legal team is fighting for compensatory damages to cover all your medical expenses, including:

revision surgeries
hospital stays
doctor’s appointments
home health care
medications
rehabilitation
medical supplies (such as wheelchairs)

We are also seeking damages to cover all the past and future wages you are losing out on from being too injured to work.

In addition, we are pursuing “pain and suffering“, which is often far greater than your medical bills and lost wages.

Finally, we will ask the judge for punitive damages to punish Exactech for allowing defective inserts to be implanted into patients. There may be evidence that indicates Exactech knew about its problems for several years and took no action to correct the defects.

Exactech’s recalled implants received “fast-track” 501(k) clearance from the FDA.

6. What is the status of the Exactech litigation?

Dozens of implant victims have filed individual lawsuits against Exactech, and more are being filed each week. Victims are suing on such grounds as:

defective design,
manufacturing defect,
improper labeling/failure to warn, and
negligence

Considering hundreds of thousands of Exactech implants have been recalled, it is likely that tens of thousands of victims may file suit. The wheels are already in motion to combine all these lawsuits into a federal multi-district litigation (MDL).

MDLs are a common way to streamline the litigation and negotiation process in cases involving defective medical devices. Since all the Exactech victims have similar injuries and are seeking similar remedies from the same defendant, it makes practical sense for one judge to manage all the cases.

Once all the pretrial procedures are done, the MDL judge will allow a few of the plaintiffs to take their cases to trial. These are called bellwether trials.

How these bellwether trials turn out then serves as a starting point for settlement talks with all the remaining plaintiffs. If the bellwether plaintiffs won big jury awards, then Exactech may offer big settlements to avoid any more trials.

The Exactech MDL will likely be based in the Eastern District of New York. However, victims from all over the U.S. can join this MDL.⁵

7. Can I get money back if I do not need a revision surgery?

If you do not need revision surgery, you can still be reimbursed for your out-of-pocket expenses for getting a medical evaluation. Call the Exactech-Broadspire Helpline at (888) 912-0403 to start a claim.

When you call, be sure to have the following information:

The date of your joint replacement operation;
The name of the surgeon; and
The serial number of your Exactech implant (if you have it).

However, it is recommended that you not sign anything without first running it by an attorney.⁶

8. What is Exactech?

Founded in 1985, Exactech manufactures medical devices for patients with joint diseases (such as arthritis).

Exactech makes implant devices for:

shoulders,
knees,
hips, and
feet and ankles

In 2018, TPG Capital (a private equity company) acquired Exactech, converting the public company into a privately held one. Exactech is headquartered in Gainsville, Florida.⁷

TKR stands for “total knee replacement.” TAR stands for “total ankle replacement.”

9. What should I do if I am a victim?

If you were implanted with a recalled Exactech insert and had – or will have – a revision surgery, contact Shouse Law Group to discuss your case. We will fight to get you the highest financial award possible to cover all your related expenses, including pain and suffering.

We only get paid if we win your lawsuit for you. This way, you take no risks and have everything to gain.

Legal References

US Exactech Recall Information, Exactech. Letter to Exactech Knee and Ankle Surgeons, Hospitals, Health Care Professionals, Exactech (April 7, 2022). Frequently Asked Questions, Knee and Ankle Recall, Exactech.
Same. See, for example, Class 2 Device Recall OPTETRAK Comprehensive Knee System, FDA.
See note 1.
See note 1. Form letter to patients, Exactech.
Exactech Supports MDL For Recalled Hip, Knee, Ankle Prostheses, Lexis Legal News (August 23, 2022).
Exactech Recall Assistance Programs, Exactech. See note 1.
Exactech (EXAC) Gets Acquired by TPG Capital, Goes Private, Nasdaq.com (February 15, 2018). About Exactech: Company Information, Exactech.

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