Knee and Ankle Replacements
Exactech recalled the liners in their knee and ankle implants manufactured in 2004 or later because non-conforming packaging may cause the liners to degrade and fail early. This could potentially lead to bone loss and revision surgery. Surgeons implanted 147,732 of these recalled inserts in the United States.
Exactech devices are failing due to disintegration of the polyethylene (“plastic”) liner in shoulder, hip, knee and ankle implants. Degrading plastic destroys tissue and bone resulting in device loosening and unnecessary revision surgery.
Beginning in August 2021, Exactech started recalling its polyethylene medical devices. The now expanding recall, is classified by the FDA as a Class II recall: “A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.” The polyethylene, or plastic, inserts can potentially wear out early and progressively get worse over time, causing intense pain and the need for revision surgery. 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.
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. This defect may cause injury to patients and necessitate further revision surgery.
Some patients who underwent a knee or ankle replacement surgery using Exactech implants are now are experiencing:
Pain in the knee or ankle joint
Inability to bear weight on the joint
Grinding noise within the joint
Knee or ankle swelling
Instability in the joint
The need for painful revision surgery
If you are experiencing any of the above you should consult your doctor who will conduct x-rays to determine the condition of your plastic insert and recommend next steps.
Recalled Exactech knee and ankle replacements include:
Optetrak All-Polyethylene CR Tibial Components
Optetrak All-Polyethylene PS Tibial Components
Optetrak CR Tibial Inserts
Optetrak CR Slope Tibial Inserts
Optetrak PS Tibial Inserts
Optetrak Hi-Flex PS Tibial Inserts
Optetrak Logic CR Tibial Inserts
Optetrak Logic CR Slope Tibial Inserts
Optetrak Logic CRC Tibial Inserts
Optetrak Logic PS Tibial Inserts
Optetrak Logic PSC Tibial Inserts
Optetrak Logic CC Tibial Inserts
Truliant CR Tibial Inserts
Truliant CR Slope Tibial Inserts
Truliant CRC Tibial Inserts
Truliant PS Tibial Inserts
Truliant PSC Tibial Inserts
Vantage Fixed-Bearing Liner Component
In June of 2021, they announced they would be phasing out their polyethylene liners in Novation, Acumatch, and MCS hip replacement products. Hip replacements from Exactech were not officially recalled, but they have informed surgeons that the aforementioned hip replacement liners could be at risk for higher wear rates.
Exactech Connexion GXL liners include:
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 Broadshire 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
If you have an Exactech hip, ankle, or knee implant call our attorneys today. You may be entitled to compensation.