Exactech Connexion GXL Hip Implant Recall

Clinical Performance Issues with the Connexion GXL Acetabular Liner

The Connexion GXL acetabular liner is one of several components that make up a modern hip replacement system. The Connexion GXL acetabular liner fits between the acetabular cup and the femoral head or ball and is intended to provide cushion and prevent direct contact or articulation between the cup and head components. The Connexion GXL is manufactured from polyethylene and can be used with a metal or ceramic femoral head. The Connexion GXL is marketed for use with Exactech’s Accumatch, MCS, and Novation hip replacement systems.

For several decades, one of the most significant types of early hip replacement failure was osteolysis due to polyethylene wear debris. In the late 1990s, highly cross-linked polyethylene (HXLPE) was introduced to reduce polyethylene liner wear and resulting osteolysis or bone destruction. The development of highly cross-linked polyethylene was a significant advancement in hip replacement technology and was quickly adopted by most medical device companies as the preferred type of plastic for use in designing and manufacturing polyethylene liners for total hip replacement.

While most modern acetabular liners are constructed from highly cross-linked polyethylene, the Connexion GXL is one of the few acetabular liners that continued to be made of moderately cross-linked polyethylene. Other manufacturing features that differ between the Connexion GXL and other modern acetabular liners are the use of a lower irradiation dose, the lack of thermal treatment to quench free radicals, and a sterilization process utilizing gamma irradiation.

More recently, the Exactech Connexion GXL liner has come under increasing scrutiny due to growing reports of early polyethylene failure.

In January 2020, researchers from the University of Florida College of Medicine reported in the Journal of Arthroplasty regarding an unacceptable rate of failure in a series of patients implanted with the Connexion GXL liner. These patients underwent revision for osteolysis and pain or aseptic loosening between January 2009 and June 2019. Most patients in the study had acetabular components that were well-positioned which indicated that appropriate component positioning did not appear to protect patients from suffering catastrophic wear of the Connexion GXL liner. There were also no other identifiable patient factors such as high body mass index or increased activity level to associate with the early failures.

In March 2020, surgeons at the Hospital for Special Surgery in New York City reported in the Arthroplasty Today on a concerning prevalence rate of 2.5% for severe polyethylene wear and osteolysis within five years of index surgery. The study included a cohort of 204 patients implanted with the Connexion GXL acetabular liner by a single surgeon over a two-year period. The authors further noted that all acetabular cups were implanted at an appropriate abduction angle and that none of the patients had identifiable risks factors for early polyethylene wear other than high activity level.