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?
- 2. Why were they recalled?
- 3. How do I know if I have a recalled implant?
- 4. Do I need a revision surgery?
- 5. What money can I get if I sue?
- 6. What is the status of the Exactech knee replacement lawsuits?
- 7. Can I get money back if I do not need a revision surgery?
- 8. What is Exactech?
- 9. What should I do if I am a victim?
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 implants and Exactech 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 defective products 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 devices may experience:
- premature wear debris production,
- bone loss/osteolysis, 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 hip, ankle or knee replacement device 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:
- replacement surgeries
- hospital stays
- doctor’s appointments
- home health care
- medications
- rehabilitation
- medical supplies (such as wheelchairs)
We are also seeking financial compensation 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.
The recalled Exactech Optetrak knee replacement system received “fast-track” 501(k) clearance from the FDA. It consists of patellar and femoral caps, a tibial insert, and a tibial tray.
6. What is the status of the Exactech knee replacement lawsuits?
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,
- strict product liability,
- 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 verdicts, 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 products include 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 surgery, and TAR stands for total ankle replacement surgery.
9. What should I do if I am a victim?
If you or a loved one was implanted with a recalled Exactech device and had – or will have – a revision surgery, contact Shouse Law Group to discuss your legal options. Our personal injury lawyers will fight to get you the highest financial award possible to cover all your related expenses, including pain and suffering, for your implant failure.
Our law firm only gets paid if we win your recall 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. Exactech also recalled its Connexion GXL liners implanted between 2008 and 2019.
- Same. See, for example, Class 2 Device Recall OPTETRAK Comprehensive Knee System, Food and Drug Administration.
- 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.