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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.
Knee replacements are made up of different parts. A standard total knee replacement is made up of four parts:
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.
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.
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.
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:
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:
Altman-Nussbaum-Shunnarah Trial Attorneys is known nationwide for providing outstanding legal advice and excellent representation. We have recovered over $750 million in lawsuits involving 18 wheeler trucking litigation, wrongful death litigation, commercial vehicle litigation, motorcycle litigation, catastrophic litigation, and mass torts involving medical devices and bad drug litigation. Our prowess in the legal arena comes from our combined years of trial and complex litigation experience.
We founded our practice on the belief that the 7th amendment and the civil jury system is the best means to provide compensation to injured parties and deter wrongdoers from injuring others in the future.
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