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The Exactech lawsuits claim that people who have had certain replacements from Exactech Inc. implants require additional procedures to repair the damage the defective devices can cause.
Our law firm’s product liability attorneys are investigating and accepting cases where a revision surgery is required.
We have been handling product liability lawsuits since 1955. Each year, we teach 1,500 attorneys how to successfully handle these cases. We are listed in Best Lawyers in America and The National Trial Lawyers Hall of Fame.
Exactech has issued massive recalls for some of its knee, ankle, and hip replacement devices.
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:
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:
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.
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.
Synovitis
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 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.
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:
Surgeons also have been advised to closely monitor affected patients for:
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.
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:
The product liability attorneys at Levin Papantonio will work 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.
Knee, ankle, and hip replacement surgery aims to relieve pain and restore function in damaged or diseased knee, ankle, and hip joints. The procedure for each joint replacement varies.
Arthroplasty (Knee Replacement)
Per Mayo Clinic, people who have knee replacement surgery typically do so to relieve osteoarthritis-caused pain, which can be severe. This pain can make it difficult for these individuals to walk, get in and out of chairs, and climb stairs. In some cases, the pain persists even when the individual is resting.
In the replacement procedure, surgeons cut away damaged bone and cartilage from the patient’s thighbone, shinbone, and kneecap. The removed materials are replaced with a prosthesis—an artificial joint composed of metal alloys, high-grade plastics, and polymers.
Total Ankle Arthroplasty (Ankle Replacement)
As with knee replacements, people who undergo ankle replacement surgery do so to relieve the pain of an arthritic ankle. If anti-inflammatory medicines, braces, or cortisone injections do not provide adequate relief, a patient can pursue an ankle fusion, in which the surgeon fastens damaged bones together, allowing them to fuse into a single bone while healing. Mayo Clinic reports this treatment can be effective at pain relief, but it can reduce the mobility of the ankle joint, which can cause arthritis in nearby joints.
Alternatively, with an ankle replacement surgery, the surgeon removes the ends of the individual’s damaged bones and replaces them with an artificial joint composed of metal and plastic. The patient retains their ability to move the ankle, reducing the risk of arthritis in surrounding joints.
Hip Arthroplasty (Hip Replacement)
Common catalysts for hip replacement surgery include diseases, like osteoarthritis and rheumatoid arthritis, as well as osteonecrosis (when bone parts die from a drop in blood supply). Breaks and fractures from falls could also lead an individual to seek relief and function from hip arthroplasty.
As one of the body’s largest joints, the hip’s ball-and socket joint consists of the “ball” at the upper end of the thigh bone (femoral head) fitting into the hip bone’s “socket” (acetabulum) in the pelvis.
The hip replacement surgery involves the surgeon making an incision to remove damaged or diseased bone and cartilage from the hip joint. The femoral head and acetabulum are then replaced with artificial metal, plastic, and/or ceramic pieces.
1985: Exactech is founded.
2018: Exactech merges with its current parent company, TPG Capital, an investment and private equity company formerly known as Texas Pacific Group.
2004: Exactech began packaging inserts in non-conforming vacuum bags that lacked a secondary barrier layer of ethylene vinyl alcohol (EVOH). Without EVOH to augment the inserts’ oxygen resistance, the devices were subject to oxidation and premature wear when implanted.
June 28, 2021: Exactech recalls Connexion GXL hip replacement devices after patients report premature wear of the replacements due to oxidation caused from a non-conforming packaging of the devices.
August 31, 2021: Exactech initiates a recall of knee and ankle arthroplasty polyethylene inserts due to similar reports of premature wear of the devices but restricts the recall to specific labels and shelf-life parameters.
February 7, 2022: Exactech expands the August recall for knee and ankle replacements to include all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life.
This study aims to compare patient-reported outcomes between total ankle replacement (TAR), total knee replacement (TKR), and total hip replacement (THR) patient groups at one, five, and 10 years. The researchers concluded that patients were equally happy with the outcomes of their TAR, as compared with other joint replacements. Read more at Foot & Ankle Orthopaedics (July 6, 2021)
The purpose of this study was to test whether younger patients receiving TKR for osteoarthritis experience a lower implant survival rate in comparison to older patients. The research indicated that patients under the age of 60 have a higher risk of early revision compared with patients over the age of 60. Read more at Clinical Orthopaedics and Related Research (April 2004)
Researchers explore the medical condition osteolysis, a progressive disintegration of bony tissue that can lead to “aseptic loosening and catastrophic failure” of an implant. The study identifies multiple factors: surgical factors, host, and prosthesis, describing how wear particles along the joint space are dispersed into bone and throughout nearby soft tissues. Per this paper, patients typically do not experience symptoms until bone loss has progress to a point where the implant loosens or fails. Read more at Clinical Orthopaedics and Related Research (October 2004)
This study delves into the condition of osteoarthritis (OA), which is the most prevalent arthritic disease and a common cause of disability. Specifically, the researchers explore recent evidence that the effects of OA extend beyond articular cartilage, to include the integrity of multiple joint tissues. This lends to the acknowledgment that OA is a “whole joint” disease. The review centers on the effect of synovitis (synovial inflammation) in OA. Read more at Bone (August 2012)
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