The Exactech Connexion GXL Acetabular Liner has caused suffering for hip replacement patients who’ve had this medical device implanted. There are documented reports of early failure (within a year of implantation) concerning this hip replacement device.
There is nothing more frustrating than suffering after joint replacement surgery. For those who’ve had a hip replacement and experience pain, limited mobility, and/or joint loosening, the news that a second surgery is required is almost too much to bear.
According to Drug Watch:
“Exactech Connexion GXL Hip Liners are hip implants used for primary and revision hip replacement surgery. The liner is made of a type of plastic called polyethylene. Exactech claims they use a special process to make Connexion GXL liners tougher and reduce wear. Exactech markets the Connexion GXL liner as more resistant to wear and fracture, but some studies have reported osteolysis in patients implanted with the liner.
Osteolysis occurs when debris from polyethylene wear builds up in the joint. It causes the surrounding tissue and bone to degenerate. This can cause implant loosening and lead to premature revision surgery.”
Evidence of such failures has been published in two scholarly scientific journals, the Journal of Arthroplasty and Arthroplasty Today, in which two separate groups of orthopedic surgeons from different institutions found significant early wear of several polyethylene Exactech Connexion GXL acetabular liners implanted in patients.
As a result of this early wear of the Connexion GXL acetabular liners, orthopedic surgeons have been faced with informing their hip replacement patients that revision surgery is necessary due to excessive liner wear, loosening, and bone erosion surrounding the defective hip implant.
Numerous Exactech Connexion GXL acetabular liner adverse event reports, many specifically mentioning wear of the acetabular liner, have been submitted to the FDA’s MAUDE database.
According to Arthroplasty Today:
“There have been reports of early failure of highly cross-linked polyethylene acetabular liner components due to catastrophic fracture of the liner as well as initiation of cracks in the liner in the early postoperative period. Furthermore, Tower et al. showed that highly cross-linked polyethylene was more susceptible than conventional polyethylene to fatigue damage, particularly with an increased cup abduction angle. . . This review of 5 cases of catastrophic early polyethylene wear demonstrates a concerning trend with the use of the Exactech Connexion GXL liner.”
Last June (2021), Exactech published a warning letter to orthopedic surgeons concerning the early failure rate of their hip devices. In the letter, Exactech officials ask surgeons to contact hip replacement patients who had surgery less than six years ago to return to the office for a medical check-up to determine if the hip implant is failing.
Nearly 90,000 hip implant patients may be affected by this Exactech failure and should seek medical advice from their surgeon if they fear the device is failing or may cause problems in the future. Our law firm has decades of experience in litigating defective hip devices.
The Recall Notice to patients and doctors recommends X-rays every two years, even if a patient is not having any current symptoms. The recall notice states that the symptoms of premature liner wear can be:
What the recall notice fails to state is that liner failure can result in permanent bone loss, known as osteolysis. Patients who do not follow up regularly with and surgeon to obtain X-rays, may be experiencing a loss of bone which they are not aware of. There are medical reports of osteolysis and early failure in Exactech patients and products. The medical field is researching the unique “crosslinking” design.
In addition to their hip liner failure, Exactech’s hip and ankle replacement devices are subject to failure at a rate that necessitated the Florida-based company to issue recalls for both their knee and ankle devices.
According to Drugwatch, “Recalled Exactech Ultra-High Molecular Weight Polyethylene (UHMWPE) Knee and Ankle Polyethylene Inserts fit in between metal components in knee and ankle replacements to cushion joints. The recall affects tibial inserts and liner components from the following knee and ankle replacement systems: Optetrak, Optetrak Logic, Truliant and Vantage.
Exactech recalled the devices because of out-of-specification packaging that didn’t adequately protect the inserts from oxygen exposure, according to the company’s Urgent Medical Device Correction letter sent to surgeons on February 7, 2022. Exposure to oxygen can cause the inserts to degrade over time and lead to early device failure.” According to Exactech, the company’s recall of more than 147,000 knee and ankle devices was based on non-conforming packaging that failed to protect the devices from early exposure to oxygen. Evidently, the company’s knee and ankle implants are packaged in vacuum-sealed bags that are designed to protect the device. However, the company acknowledges that “most of our inserts manufactured since 2004 were packaged in out-of-specification … vacuum bags that are oxygen resistant but do not contain a secondary barrier layer containing ethylene vinyl alcohol (EVOH) that further augments oxygen resistance.”
Like their hip liner, the Exactech ankle and knee replacement devices may lead to bone loss, accelerated wear, debris production which can migrate into other areas of the body, component fatigue and component cracking or fracture that will require revision surgery to correct.
According to the FDA, this is a Class 2 recall which means that the failed devices may cause temporary but reversible injury.
The Optetrak Knee device has been on the market since 1992 and Exactech claims the packaging problems originated in 2004. Data from Australian, New Zealand and United Kingdom registries have shown the implant has significantly higher overall revision rates compared to other knee implants, according to the company’s recall letter.
The Optetrak Knee has been the subject of numerous lawsuits prior to this recall and due to premature failure, pain, and instability.
If you or a loved one has had one of the recalled Exactech knee or ankle devices implanted, contact your surgeon immediately.
At Rheingold, Giuffra, Ruffo, & Plotkin we have decades of experience representing clients who have suffered as a result of failed medical devices such as defective hips, ankles, and knees. Contact us for a free case evaluation.
If you suffered negative side effects after receiving an Exactech Connexion GXL acetabular liner, you may have a viable defective product claim. Individuals who were harmed by a defective medical device have the right to seek compensation for the resulting damages caused by Exactech’s hip liners. Damages may include reimbursement for loss of wages, compensation for past, current, and future medical expenses involving the defective device, as well as pain and suffering.
At Rheingold Giuffra Ruffo & Plotkin LLP, our firm is passionate about advocating for the rights of the injured. We provide each client with personal attention in order to better meet their needs, and our experienced attorneys specialize in complex cases.