Exactech Lawsuits – Knee, Ankle and Hip Replacement Compensation
According to Exactech, inserts manufactured since 2004 were packaged in non-conforming vacuum bags. Although the bags are oxygen resistant, they do not feature a secondary barrier layer of ethylene vinyl alcohol (EVOH). The purpose of EVOH is to bolster the device’s resistance to oxygen.
As a result of this lowered resistance, oxygen diffuses to the ultra-high molecular weight polyethylene (UHMWPE) insert, causing increased oxidation of the material, as compared with inserts packaged with the secondary barrier layer.
The added oxygen can cause degradation of the UHMWPE, prompting the following:
- Accelerated wear debris production
- Bone loss
- Disintegration of bone cells (lysis)
- Component fatigue cracking/fracture
- Necessary corrective revision surgery
The Food and Drug Administration (FDA) classified the recall as a Class II recall. If you had a joint replacement using any of these products or are not sure which brand of polyethylene inserts were used in your procedure, call our offices immediately.
Around 147,732 inserts implanted in the U.S. since 2004 were produced with non-conforming packaging, according to Exactech’s notice. The recall comprises all non-conforming Exactech Knee and Ankle UHMWPE inserts in the field, regardless of shelf life.
Surgeons have been advised to AVOID implanting nonconforming replacements.
Exactech has published an online list of affected devices, product codes, descriptions, and serial numbers. Recalled devices include those from the following Exactech knee and ankle systems:
- Optetrak: 60,926 implanted units since 2004
- Optetrak Logic: 60,518 implanted units since 2004
- Truliant Knee Replacement: 24,727 implanted units since 2004
- Vantage Ankle Implants: 1,561 implanted units since 2004
Connexion GXL Hip Replacement
On top of these knee and ankle device recalls, Exactech has experienced similar problems with its hip replacement devices.
On June 28, 2021, the company sent an Urgent Healthcare Professional Communication to surgeons, hospitals, and healthcare professionals. The letter stated that a percentage of Connexion GXL patients had experienced wear that led to proximal femoral and acetabular osteolysis.
This recall involved around 90,000 hip replacements with Exactech Connexion GLX Liners.
If you had a Hip Replacement using Connexion materials, please call our offices immediately to see if you are at risk and eligible for compensation.
Knee, Ankle, and Hip Replacement Patients Might Not Know About the Recall
Exactech has NOT directly notified individuals who received the recalled knee, ankle, or hip replacements. Rather, the company provided a template letter for surgeons who were requested to send the letter to any patient who might have been impacted by the defective medical devices.
If a patient moved, or their surgeon retired or simply failed to send out any notification, that patient would have no way of knowing their replacements could cause injury or harm.
Ankle, knee, and hip replacement recipients can visit Exactech’s online tool to determine whether their replacement has been recalled. You will need to enter the serial number of your device, which can be found in your medical records.
The premature degradation of Exactech’s knee, ankle, or hip replacements can prompt a series of medical problems. If you think you have an Exactech replacement insert and are concerned, please call our offices immediately to speak with our team.
Synovitis refers to a medical condition characterized by inflammation of the synovial membrane, which lines the joints in the human body. The swelling causes pain, especially in association with movement of the joint. If synovitis persists long term, it can result in the affected joint’s degeneration.
Signs of synovitis include the presence of nodules, or hard lumps, and swelling, along with joint pain or tenderness.
If you are experiencing symptoms of Synovitis, please call our offices immediately to speak with our team. You may be eligible for compensation.
Osteolysis of the Bone
Osteolysis is a pathological process in which osteoclasts actively break down bone tissue, releasing minerals and prompting calcium to transfer from bone tissue to the blood. This condition often manifests near a prosthesis or artificial joint replacement, including total knee and hip replacements.
In the case of replacement devices, the body tries to clean up metal or plastic wear particles from the artificial ball and socket joint. The effort initiates an autoimmune reaction that triggers resorption of living bone tissue. Ultimately, osteolysis brought on by replacement devices can cause an implant recipient to suffer broken bones and/or loosening of the implant.
This process can commence within twelve months of the knee, ankle, or hip replacement implantation and is typically progressive, requiring that the prosthesis to be replaced during a revision surgery.
If you are experiencing symptoms of Osteolysis, please call our offices immediately to speak with our team. You may be eligible for compensation.
Revision of the Implant With a Replacement Insert
Although the U.S. does not maintain a registry for joint replacement, a high-level review of registry data (provided by Exactech) from Australia, New Zealand, and the United Kingdom reveals a significant failure rate of Exactech’s knee implants:
Australia: 10% knee revision rate, including 374 revisions out of 3,684 Exactech Optetrak knee replacements impacted by the polyethylene component. The cause of polyethylene wear in revisions increased three- to seven-fold in Optetrak-PS/Optetrak (the most popular combination of total knee replacements)
U.K: Exactech Optetrak TKR System using the cruciate-retaining femoral component showed statistically significant increased cumulative revision rates
New Zealand: 63 total knee revision procedures out of 661 primary Optetrak total knee replacements and a two-fold increase in revision rate compared with all other primary total knee replacements
Exactech advises surgeons to maintain an index of suspicion for their knee and ankle replacement patients who report the following symptoms:
- New or worsening pain
- Inability to bear weight
- Grinding or other noise
- Instability in knee or ankle
Surgeons also have been advised to closely monitor affected patients for:
- Potential wear
- Associated failure modes
If a surgeon suspects that the joint replacement device has failed, Exactech recommends the surgeon perform X-rays. The company advises against the pre-emptive removal of Exactech knee and ankle devices if the device is functioning and the patient is not experiencing pain.
In the event that premature polyethylene wear is detected, Exactech recommends that surgeons consider revision surgery in line with their clinical judgment.
If you think you might be eligible for revision surgery, please call our offices immediately to speak with our team.
You should be aware that Exactech has retained the services of a settlement adjusting company, Broadspire, to handle claims reimbursement for individuals who participate in this process. Details for how to file a claim appear on Exactech’s website.
Please know, however, that Exactech asserts it will cover only claimants’ “out-of-pocket expenses.” The company will not give you a free examination or replacement procedure. Rather, you would need to cover these expenses on your own and cross your fingers that Exactech will reimburse you.
Furthermore, it is possible that filing an Exactech recall claim in this manner could cause you to lose important rights in any future claim you might want to pursue.
We strongly advise you to talk to our attorneys BEFORE you reach out to Exactech or Broadspire.
An Exactech knee, ankle, and hip recall settlement could cover the following:
- Any medical treatment, including surgery costs, after your device replacement device fails
- Medical expenses (past and future)
- Pain and suffering (past and future) resulting from injuries, treatment, and recovery
- Lost wages (past and future)
- Loss of earning capacity
- Loss of enjoyment of life (past and future)
- Possible punitive damages
The product liability attorneys at Coffey McPharlin Trial Law will fight to get you the maximum financial compensation for the losses you have suffered as a result of your defective Exactech knee, ankle, or hip replacement.