Exactech Hip Replacement Recalls

Because prosthesis implants can be exceptionally adept in helping people regain their mobility without pain and discomfort, thousands of patients have been implanted with replacement systems. However, hip, knee, and ankle implants have an established history of severe issues and defects.

Beginning in the summer of 2021, Exactech began recalling polyethylene liners for some of its knee and ankle implants, specifically Exactech Connexion GXL acetabular liner in hip replacements. The manufacturer issued the recall due to early failure of the liner from wear and tear, stating that: “There is a risk of edge-loading and premature prosthesis wear, so it is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.”

By February 2022, the company expanded its recall to include “all knee and ankle arthroplasty polyethylene inserts packaged in non-conforming bags regardless of label or shelf life.” In June of 2021, Exactech issued a letter informing its purchasing doctors that the company was phasing out the polyethylene Exactech GXL Connexion liners used in its Novation, Acumatch, and MCS systems hip replacement products. However, this is not a recall, and the company will transition to its new XLE polyethylene liner infused with Vitamin E.

Reasons for recall

Patients with this liner implanted during a revision or primary hip replacement surgery could need additional procedures to repair damage caused by the medical device. However, it was not until 2022 that most consumers learned of the design issues when the FDA expanded recalls for the potentially dangerous product, which affected nearly 150,000 patients. After receiving numerous reports of adverse effects associated with the defective systems, the FDA issued a Class II recall, which is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences.”

After extensively testing the clinical performance of the Exactech polyethylene inserts, results confirmed that most of their total knee replacements and total ankle replacements with polyethylene components and inserts manufactured after 2004 were packaged in defective vacuum bags. These defects could have exposed products in this packaging to oxygen, which significantly degrades the liner, causing:

Fractures
Cracks
Other adverse effects occur earlier than expected, sometimes as early as one-year post-implantation

GXL hip liners also pose a risk for premature wear. Exactech informed surgeons that patients with hip replacements that use the GXL liner could risk higher wear rates under certain conditions. This warning came after the company observed that .118% of patients who had implants for 3 to 6 years after initial surgery might have earlier wear on the liners.

Exactech listed contributing factors to premature GXL liner wear, including:

Larger femoral heads
Higher patient activity levels
Devices that were implanted by using a direct anterior hip surgery approach

Recalled Exactech products

Exactech does not describe their transition from GXL hip liners as a recall, but similar to the recall process, hip replacement patients should speak with their surgeon. They can confirm the model and make of your hip replacement and whether an Exactech GXL liner was implanted.

While on the market, all three generations of the Exactech knee systems have had polyethylene inserts packaged in defective bags. Exactech recalled all Optetrak, Truliant, and Vantage brand knee and ankle replacement liners that were manufactured as early as 2004. Additionally, the company advised surgeons not to implant defective products and to return any conforming and nonconforming devices to Exactech.

Recalled Exactech knee and ankle implants 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
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

What to do if you have an Exactech Connexion GXL hip liner

Symptoms of polyethylene wear are associated with bone loss or excessive particle debris released from the degraded liner. However, some people may suffer bone loss, also known as osteolysis, without symptoms. Contact your surgeon to determine whether you should monitor your implant for potential future issues, even if you do not currently have any symptoms.

Premature prosthesis wear can also cause one or more of the following:

New or worsening pain
Inability to bear weight in the area
Device loosening
Grinding or other noises coming from the implant
Recurrent swelling
Infections
Failure to bond to the bone
Instability in the knee or ankle
Component fatigue, cracking, or fracturing
Tissue and nerve damage
Metallosis or metal debris shed into the bloodstream
Revision surgery
Clicking in your knee, ankle, or hip
Pain while walking
Swelling in the joint

You should contact your surgeon immediately if you have a hip implant with a GXL liner. Exactech recommends doctors closely monitor patients with recalled inserts for potential osteolysis and excessive wearing by using imaging to determine excessive wear or bone and tissue damage.

Some patients have contacted Exactech to be reimbursed for out-of-pocket costs, such as medical bills from doctor visits or potential surgery. Lawyers across America are currently investigating Exactech claims, and patients may choose to file Exactech replacement lawsuits in an attempt to be compensated for:

Medical bills
Lost wages
Pain and suffering
Other damages

Goldberg & Rosen can help victims of the GXL Hip Liner Recall

Hip implants should provide enhanced joint function and relief from pain. However, you may face serious medical complications when implanted with a defective device such as the Connexion GXL.

Our legal team at Goldberg & Rosen will work relentlessly on your behalf, holding the manufacturer accountable and ensuring you receive the compensation you deserve. During your initial evaluation with our legal team, we’ll review the facts of your case and determine whether you’re entitled to recover damages.

Schedule A Consultation

If you or a loved one have been the victim of negligence or misconduct, please do not hesitate to contact among the best attorneys Miami has available at Goldberg & Rosen today to receive expert guidance about your legal options, as well as a free and confidential case evaluation.