An OPTETRAK lawsuit is a legal claim for financial compensation by plaintiffs who need revision surgery due to their recalled Exactech knee or ankle implant device. In this article, our mass torts defense attorneys discuss:
- 1. Which knee and ankle inserts have been recalled?
- 2. Why are they being recalled?
- 3. What are the symptoms of a failing Exactech insert?
- 4. Will I need a revision surgery?
- 5. What is the current state of the litigation?
- 6. How much money can I get?
- 7. What should I do if my insert was recalled?
1. Which knee and ankle inserts have been recalled?
The medical device manufacturer Exactech has recalled the following knee and ankle polyethylene inserts that were manufactured from January of 2004 to January of 2022.
System | Recalled Device |
OPTETRAK® |
|
OPTETRAK Logic® |
|
TRULIANT® |
|
VANTAGE® |
|
This recall began on August 31, 2022, and was expanded on February 7, 2022, to include all knee and ankle arthroplasty polyethylene inserts packed in non-conforming bags despite their label or shelf life. A total of 147,732 inserts are being recalled.1
2. Why are they being 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 a 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
Patients with recalled ankle or knee implants can sue Exactech for all the costs associated with their revision surgery.
3. What are the symptoms of a failing Exactech insert?
Potential signs that a recalled Exactech insert is degrading are:
- pain
- grinding noises
- loss of ability to bear weight
- knee or ankle instability
- swelling
Anyone implanted with a recalled Exactech insert and who is experiencing symptoms is advised to consult with their doctor.3
4. Will I need revision surgery?
Some patients implanted with a recalled Exactech knee or ankle insert may need a corrective revision surgery.
Note that asymptomatic patients are not advised to get surgery preemptively. Instead, their doctors can monitor their inserts through periodic X-rays. And there may be other treatment options available other than additional surgeries.4
5. What is the current state of the litigation?
Litigation against Exactech is just beginning. Implant victims are expected to sue for:
- defective design,
- failure to warn, and
- negligence.
It is likely that all the plaintiffs’ lawsuits will be consolidated into a multi-district litigation (MDL), which helps to streamline the litigation process. Eventually a few bellwether trials will go forward. And the result of these verdicts will then set the stage for negotiations with the remaining MDL plaintiffs.
6. How much money can I get?
Victims of the recalled Exactech knee or ankle inserts may be able to recover compensatory damages for:
- medical bills, especially for the revision surgery and rehabilitation;
- lost wages from being unable to work during the recovery time; and
- pain and suffering.
Knee or ankle implant patients experiencing pain should contact their doctor.
7. What should I do if my insert was recalled?
First contact your physician to discuss your options. Then call Shouse Law Group to discuss filing a lawsuit against Exactech in pursuit of the largest settlement possible under the law.
Legal References
- Exactech Recall Information, Exactech.
- See note 1. See also Australian Orthopaedic Association National Joint Replacement Registry: Hip, Knee & Shoulder. Annual Report 2021. Adelaide, Australia: AOA, 2021; United Kingdom National Joint Registry: 18th Annual Report. Annual Report 2020. United Kingdom: United Kingdom National Joint Registry, 2021; The New Zealand Joint Registry: Twenty-One Year Report. Annual Report 2020. New Zealand: New Zealand Joint Registry, 2020; Australian Orthopaedic Association National Joint Replacement Registry: Optetrak-PS/Optetrak Total Knee; Investigation 2021. Adelaide, Australia: AOA, 2021; Australian Orthopaedic Association National Joint Replacement Registry: Optetrak-CR (cemented)/Optetrak-CR (cemented) Total Knee Investigation 2021. Adelaide, Australia: AOA, 2021; Australian Orthopaedic Association National Joint Replacement Registry: Optetrak-PS/Optetrak-PS Total Knee Investigation 2021. Adelaide, Australia: AOA, 2021. Australian Orthopaedic Association National Joint Replacement Registry: Optetrak-PS/Optetrak RBK Total Knee Investigation 2021. Adelaide, Australia: AOA, 2021.
- See note 1. See also Total Knee Arthroplasty (TKA/TKR), Medscape.
- See note 1.