Exactech Hip Recall Lawsuit for Connexion GXL Liners

Exactech faced individual product liability lawsuits and class action claims over complications linked to Connexion GXL acetabular polyethylene liners, which were used in certain hip replacement systems. These defective components were found to degrade prematurely, increasing the risk of hip failure and the need for revision surgery.

The Connexion GXL liners were recalled after reports indicated that the polyethylene material could deteriorate in the body, leading to a condition known as osteolysis. As the liners broke down, debris could accumulate in the joint space, triggering bone and tissue loss, implant loosening, and ultimately device failure.

Nearly 130,000 Exactech hip replacements since 2004 were believed to have included the recalled Connexion GXL liners, which exposed recipients to a higher risk of long-term complications such as:

  • Osteolysis
  • Hip Pain
  • Stiffness
  • Loss of Mobility
  • Hip Implant Failure

Exactech acknowledged that it had received adverse event reports involving early wear and liner degradation, including cases of proximal femoral and acetabular osteolysis. However, lawsuits alleged that the company failed to take timely corrective action or notify surgeons and patients. Instead, plaintiffs claimed the manufacturer prioritized profits and quietly worked to develop a redesigned liner before fully disclosing the risk.

Legal action was taken on behalf of individuals who required hip revision surgery due to problems with a recalled Exactech liner. Lawsuits sought financial compensation for medical expenses, pain and suffering, and other damages linked to the defective implant.

Exactech Hip Liner Recall Information

On June 28, 2021, an Exactech Connexion GXL hip recall was issued, and an Urgent Dear Healthcare Professional Communication was sent to surgeons, hospitals, and healthcare providers. However, many individuals who received these defective hip replacement liners remained unaware that their implant may have been recalled.

Approximately 89,050 defective hip liners were implanted in patients in the U.S. since 2007. The action was classified as a Class II medical device recall, indicating a risk of serious but potentially reversible health problems. In many cases, these issues resulted in the need for revision surgery and led to unnecessary medical costs, pain and suffering, and additional risks that could have been avoided.

On August 11, 2022, the recall was expanded. A new Dear Healthcare Professional (DHCP) letter was issued, warning that another 40,105 acetabular hip liners used in the Connexion, GXL, Acumatch, MCS, and Novation systems may also be defective.

2022 Exactech Hip Recall Expansion Products

  • Acumatch GXL Acetabular Liners
  • MCS GXL Acetabular Liners
  • Novation GXL Acetabular Liners
  • Exactech All Polyethylene Cemented Acetabular Cup
  • Acumatch Conventional UHMWPE
  • MCS Conventional UHMWPE
  • MCS Conventional UHMWPE liners

Exactech stated that GXL inserts manufactured since 2004 were packaged in out-of-specification vacuum bags that lacked a secondary oxygen barrier. As a result, oxygen exposure during storage may have degraded the mechanical integrity of the polyethylene liner.

The manufacturer warned that these devices could be susceptible to accelerated wear, bone loss, and component fatigue or fracture, often leading to revision surgery.

What Was the Problem With Exactech Hip Replacements?

Recalled Connexion GXL hip liners were associated with an increased risk of failure, which could lead to revision surgery following symptoms such as pain, instability, or reduced mobility.

A total hip replacement system typically includes the following components:

  • Acetabular Cup: A metal cup that fits into the hip socket
  • Femoral Head: A ball which sits at the top of the femur which fits into the acetabular cup, allowing the joint to move.
  • Femoral Stem: A metal stem attached to the top of the femur, which is attached to the femoral head.
  • Liner: To provide cushion and prevent wear where the head fits into the acetabular cup.

The recalled polyethylene liner served as a shock absorber and cartilage substitute. When the liner degraded or wore prematurely, the entire hip replacement system could fail.

Exactech reported that the Connexion GXL liner exhibited early linear and volumetric wear, especially in patients with larger femoral heads (e.g., 36mm or larger), thinner liners, or implants placed using a direct anterior approach. These wear patterns resulted in edge loading, which increased the likelihood of complications in higher-activity patients.

Symptoms Reported With Exactech Hip Failures

Many individuals with defective Exactech hip liners experienced one or more of the following symptoms:

  • New or worsening hip pain
  • Hip stiffness
  • Pain
  • Loss of mobility
  • Grinding, clicking or other noises from the hip implant.

In cases where device failure was confirmed, hip revision surgery was often required to replace the defective components. Some surgeons opted to exchange only the polyethylene liner, depending on the condition of the surrounding implant components.

Although Exactech did not recommend preventive removal of functioning implants, the recalled hip liners sometimes necessitated ongoing medical monitoring to detect early signs of wear or failure.

Allegations Raised in Exactech Hip Lawsuits

Personal injury claims and Exactech Connexion GXL hip class action lawsuits alleged that the manufacturer:

  • Knew about the Exactech hip liner problems long before announcing the recall, but failed to adequately investigate the cause of the premature hip failures;
  • Failed to warn surgeons and consumers that the polyethylene hip liner may degrade and wear, leading to pain and other hip complications that may require additional surgery;
  • Negligently continued to sell dangerous and defective hip liners, while concealing information from consumers, regulators and the medical community;
  • Delayed issuing a full Exactech hip liner recall, allowing defective devices to continue to be implanted in patients;
  • Placed desire for profits before consumer safety.

Hip Replacement Lawyers

Following the recall of Exactech Connexion GXL and other hip liner components, individuals who underwent total hip replacement surgery since 2007 were encouraged to explore their legal rights and pursue compensation for complications associated with the defective polyethylene liners.

The hip replacement lawyers at Saiontz & Kirk, P.A. previously provided free case evaluations to help individuals determine whether they may qualify for a lawsuit settlement. Legal representation was offered on a contingency fee basis, meaning clients paid no out-of-pocket costs unless a recovery was obtained.

Many individuals were unaware of the specific implant components used during their surgery. The legal team assisted in reviewing medical records to confirm whether a recalled Exactech hip liner was involved and to evaluate potential claims for financial compensation.

Each case was assessed based on the circumstances of the hip replacement and any resulting complications. Individuals who qualified were offered the opportunity to pursue a claim as part of the Exactech litigation.