Exactech Knee and Ankle UHMWPE Inserts
On February 7, 2022, Exactech sent an Urgent Medical Device Correction notice to knee and ankle surgeons, hospitals, and healthcare professionals. The notice informs readers that the company has expanded its August 31, 2021, recall to include “all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life.”
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.
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, products 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
Knee and Ankle Patients Might Not Know About the Recall
Exactech has not directly notified individuals who received the recalled knee or ankle 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.
Knee and Ankle recipients can visit Exactech’s online tool to determine whether their replacement has been recalled. A patient will need to enter the serial number of their device, which should be found in the medical records.
Knee and Ankle Replacement Injuries & Side Effects
The premature degradation of Exactech’s knee or ankle replacements can prompt a series of medical problems.
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.
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 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 or ankle replacement implantation and is typically progressive, requiring that the prosthesis to be replaced during a revision surgery.
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.
Knee and Ankle Replacement Lawsuits and Settlements
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.
Exactech asserts it will cover only claimants’ “out-of-pocket expenses.” The company will not pay for an examination or replacement procedure.
Furthermore, it is possible that filing an Exactech recall claim in this manner could cause the patients to lose important rights in any future claim they might want to pursue.
We strongly advise that patients speak with their attorneys, such as LCHB, in connection with the Exactech or Broadspire.
What Compensation is Recoverable in an Exactech Knee or Ankle Replacement Lawsuit?
An Exactech knee or ankle 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