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Exactech, Inc. Recalls Connexion GXL Hip Implant Liners Over Safety Concerns

10/19/2021
Defective Medical Devices
BY

Exactech, Inc. is the manufacturer of acetabular polyethylene hip liner components that are used in certain hip implant systems. On June 28, 2021, Exactech, Inc. issued “Urgent Medical Device Correction” letters to agents, representatives, and distributors in possession of Exactech Connexion GXL polyethylene liners According to the United States Food and Drug Administration (FDA) class 2 recall notice, Exactech has recalled numerous Connexion GXL acetabular polyethylene hip liners used in hip implant systems.

The reason for the recall, as stated on the FDA’s recall notice is because of a risk “of edge-loading and premature prosthesis wear . . . in a specific subset of patients with certain implant configurations and surgical implant positioning.” Specific details about patient injuries are not identified on the recall notice.

Acetabular Liners Are Used in Most Hip Replacement Systems

An acetabular liner is one component of a total hip replacement system, designed to treat hip conditions including arthritis, osteonecrosis, and fracture. The hip is a ball-and-socket joint. The ball is called the femoral head, whereas the socket is created by part of the pelvis bone, the acetabulum. In a normal hip, the surfaces of the ball and the socket are covered by cartilage that – along with the synovial membrane – allow movement in the ball-and-socket joint. The ball portion of the femur bone – the femoral head – lies against the acetabular cup space, which is lined with a plastic or ceramic component, called an acetabular liner.

In a total hip replacement, damaged bone and cartilage are removed and replaced with prosthetic parts. The acetabular liner goes between the new femoral head, or the ball, and the acetabulum is replaced by a cup that serves as the socket. An acetabular liner is used between the prosthetic ball and socket to allow a smooth gliding surface. Acetabular liners may be made of polyethylene (plastic), ceramic, or metal.

The Exactech Connexion GXL acetabular liners are made out of moderately cross-linked non-vitamin E polyethylene. The liners are used with other Exactech hip replacement components. Hip replacement lawyers who routinely handle defective hip implant cases are thoroughly investigating potential Exactech claims, as a substantial number of patients may have been injured by the Exactech products.

Potential Injuries Associated with Defective Exactech Connexion GXL Liners

Whenever a medical device faces a recall, the first question is why. Unfortunately, defective products may not face a recall until many patients have already suffered injuries. One recent study concerning Exactech Connexion GXL liners suggested that wearing of the liners may have resulted in early failures of total hip replacements.

A second study reviewing 5 cases of “catastrophic early polyethylene wear” of the Exactech Connexion GXL liners demonstrated “a concerning trend” with the device. Early wear was clearly visible on patient x-rays. The early wear of these liners – which should not happen – has caused patients to experience injuries, some of which include the following:

  • Osteolysis, which is the degeneration of bone tissue Pain
  • Loosening of any of the hip replacement components
  • Inflammation
  • Stiffness
  • Difficulty with mobility

Many of the injuries associated with failed Exactech Connexion GXL liners are similar to those sustained as a result of other defective hip replacement components and systems. When one component of a hip replacement system fails, the entire medical device cannot operate as intended and provide relief for a patient.

Instead, patients experience injuries that often require a revision surgery to remove and replace the defective hip replacement implant. Revision procedures are invasive and painful for patients and are often considered a type of injury when assessing potential legal claims against the manufacturers of defective medical devices.

Contact a Defective Medical Device Attorney at Searcy Denney for a Free Consultation

If you have suffered complications following hip replacement surgery, it may be time to consult with a defective medical device attorney who can evaluate your situation and determine whether you have any potential legal claims.

At Searcy Denney, we represent clients from all across the country who have suffered from defective and dangerous products. To receive your free case evaluation, contact Searcy Denney today by calling (800) 780-8607 or by completing a free case evaluation form on our website.

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