Exactech Knee Replacement Lawsuit Lawyer

Exactech (February, 2022) issued an urgent medical device correction expanding an earlier limited recall of their OPTETRAK Comprehensive Knee System. The recall includes all knee arthroplasty polyethylene inserts packaged in non-conforming vacuum bags, regardless of the label or shelf life of the device. Exactech noted 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.

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What Knee Replacements are Part of the Exactech Recall?

The defective components affected by 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.

Parts of a Standard Total Knee Replacement

Knee replacements are made up of different parts. A standard total knee replacement is made up of four parts:

THE FEMORAL COMPONENT

A metal piece that attaches to the thigh bone.

THE TIBIAL TRAY

A metal piece that fits into the shin bone.

THE PATELLAR COMPONENT

A piece of plastic that fits onto the kneecap.

THE TIBIAL POLYETHYLENE INSERT

A plastic insert that fits between the femoral component and the tibial component, and acts as the new cushion for the replaced knee joint.

A metal piece that attaches to the thigh bone.

A metal piece that fits into the shin bone.

A piece of plastic that fits onto the kneecap.

A plastic insert that fits between the femoral component and the tibial component, and acts as the new cushion for the replaced knee joint.

THE PROBLEMS WITH THE EXATECH DEVICE

Exactech found that one of the packaging layers for the polyethylene insert used in the total knee 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. 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 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.

Symptoms of an Exactech Knee Failure?

Your surgeon may contact you if they are concerned about the knee replacement device that you received. However, do not wait to hear from your surgeon if you are experiencing any of these symptoms:

New or worsening knee swelling Pain while walking Inability to bear weight Grinding or other noise in the knee Instability Clicking in your knee

Legal Options

Exactech has committed to assisting patients with certain out-of-pocket costs related to clinical follow-up and any revision surgery that may be necessary. However, you may be entitled to more compensation than Exactech is offering. You may be able to recover for damages including:

Possible compensation you could receive includes:

• Costs due to doctor visits.
• Medication reimbursement.
• Nursing and other related care costs
• Money for days you were not able to work due to your injury.
• Money for future income you cannot make if your injury does not allow you to work.