Details about the Exactech knee implant recall
Exactech Recall Issued in 2022
In February 2022, Exactech issued an urgent medical device correction expanding an earlier limited recall of their OPTETRAK Comprehensive Knee System. The Exactech recall includes all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming vacuum bags regardless of the label or shelf life of the device. According to Exactech, the reason for the recall is the inserts were packaged in vacuum bags that did not conform to required specifications. This defect may cause injury to patients and necessitate further revision surgery. The U.S. Food and Drug Administration (FDA) classified this action as a class II recall.
What Knee Replacements are Part of the Exactech Recall?
The Exactech recall include the following:
- OPTETRAK® All-polyethylene Tibial Components
- OPTETRAK® Tibial Inserts
- OPTETRAK Logic® Tibial Inserts
- TRULIANT® Tibial Inserts
- VANTAGE® Fixed-Bearing Liner Component
Since 2004, over 60,000 units each of OPTETRAK® and OPTETRAK Logic® components have been implanted in patients in the U.S. Approximately 25,000 units of the TRULIANT® inserts and 1,500 of the VANTAGE® Fixed-Bearing Liner Components implanted in patients are also affected by the recall. If you are not sure whether you received a component affected by the recall, you should contact your physician who will check the serial number of your component against the list of affected devices provided by Exactech.
Exactech Lawsuit: The Problems with the Exactech Device
Exactech found that one of the packaging layers for the polyethylene insert used in both the total knee replacement and the total ankle replacement did not conform to specifications. It found that the layer may allow oxygen from air to diffuse into the plastic insert before it is implanted in the knee or ankle. When a large amount of oxygen spreads into the plastic insert during storage, before the insert is implanted, it can lead to oxidation. Oxidation can cause the components of the implant to wear out prematurely and cause damage to the plastic after it is implanted in the patient’s body causing injury to the patient. Without the plastic insert, there is no cushioning to absorb the impact of movement causing pain and injury to the patient.
What Exactech Polyethylene Patients Should do
If it is determined that you have an Exactech knee or ankle product that is included in the recall, you have several options. Exactech has retained Broadspire, a settlement adjusting company, to oversee the claims reimbursement process. Patients who have been contacted by their surgeon about a follow-up are directed to contact the Exactech-Broadspire Helpline to initiate a claim. It is important to keep in mind the Broadspire represents the interests of Exactech, therefore, it is not advisable to contact the Exactech-Broadspire Helpline before speaking with an personal injury attorney about your case. The Exactech-Broadspire settlement only covers reimbursement for out-of-pocket expenses and costs incurred in relation to evaluation and treatment for revision surgery. A reimbursement settlement assessed by Broadspire may fall far short of the actual damages you suffered. You may be entitled to more compensation than Exactech is offering.
You may be able to recover financial compensation for damages including:
- Lost wages if you missed or will miss work because of your ankle or knee replacement
- Pain and suffering
- Related medical expenses
How much is an Exactech knee replacement lawsuit worth?
Often in personal injury cases, lawyers look at past settlements and verdicts to inform the value of a client’s claim. This is because past case values are a good gauge of the general value of a particular type of case. Nevertheless, we treat our clients independently based on their specific circumstances. The severity of the claimant’s injuries, complications suffered by the claimant, and other specific circumstances surrounding their injury are all factored into the computation of the value of claimed damages. Every device litigation case is different and every individual claim is different. How much compensation you can recover will depend on the specific facts of your case. Past settlements are no guarantee of future awards, but we will work hard to get our clients the highest settlements possible.
Speak to a Lawyer About Your Next Steps
If you had a knee or ankle replacement with a recalled Exactech product, you should speak to a lawyer about your legal options. Our law firm team has successfully resolved such cases. If you have been affected by the Exactech recall we are ready to help you. We offer a free consultation, so call us today to speak with a member of our legal team.
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