Patients implanted with an Exactech Connexion GXL liner during a total hip replacement procedure may experience problems with their hip replacement. In some cases, these liners have failed more quickly than expected due to liner wear, requiring some patients to undergo a premature revision hip replacement surgery.
In the summer of 2021, the manufacturer issued a recall for some models of these liners. The reason Exactech gave was “Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.”
Symptoms of medical complications resulting from Exactech Connexion GXL liner wear may include:
- Limited mobility.
- Osteolysis — disappearance or degeneration of bone tissue.
- Revision surgery due to device failure.
All hip replacements contain several different parts, often including an acetabular liner. When a person’s hip is replaced, typically a metal cup is inserted into the hip socket (acetabulum), often anchored with screws.
An acetabular liner, typically made of some form of plastic or ceramic, is often inserted into this acetabular cup. A femoral head component — a spherical piece of metal intended to replicate the top or “ball” of a person’s femur bone — sits against the acetabular liner.
The Exactech Connexion GXL acetabular liner is intended for use with other Exactech hip components implanted during total hip replacement.
At least two recently published studies have reported earlier than expected failure of the Exactech Connexion GXL acetabular liners due to wear.
Early Failure of Implant
Orthopedic surgeons at the Department of Orthopedics and Rehabilitation at the University of Florida College of Medicine authored one recently published study discussing early failure of the Exactech Connexion GXL liners. The surgeons reviewed their institutional database and identified problems and failures due to wear.
Link to study: https://www.sciencedirect.com/science/article/pii/S0883540319311921
These physicians reviewed patient data from January 2009 to June 2019 for all patients who had revision surgery after being implanted with the Exactech Connexion GXL acetabular liners at their institution. These orthopedic surgeons found that all of the patients who had to have a revision surgery, or revision surgery had been recommended, after being implanted with an Exactech Connexion GXL acetabular liner demonstrated radiographic osteolysis around the liners. This means X-rays of their hips showed bone loss and destruction to the hip socket (acetabulum).
The researchers expressed concern that the Exactech Connexion GXL liner could be prone to early failure. Patients included in this study were diagnosed with hip implant failure after having their original hip implant surgery, on average, less than five years earlier, “a timeframe that is uncommon in technically well-done” total hip replacement.
FDA Adverse Events
The authors also performed a U.S. Food and Drug Administration (FDA) Manufacturer and User Facility Device Experience (MAUDE) database review of the Exactech Connexion GXL liners, to determine if adverse event reports had been submitted to the FDA in connection with these hip components. This MAUDE database review yielded 83 patients who had undergone revision after being implanted with an Exactech Connexion GXL liner.
There were 22 of these patients specifically noted as having revision due to “poly wear” or “osteolysis.” When reported for these adverse events, the average time between the Exactech Connexion GXL liner’s initial implantation to revision surgery was approximately 6.5 years.
These surgeons recommended that doctors keep a close eye on patients who have been implanted with these hip implant liners.
Wear and Osteolysis
Another group of orthopedic surgeons, this time from the Hospital for Special Surgery in New York, authored a study published a few months later in the journal Arthroplasty Today. The study discussed “catastrophic early polyethylene wear demonstrat[ing] a concerning trend with the use of the Exactech Connexion GXL liner.” These physicians noted that the Exactech Connexion GXL liner seemed linked to “severe polyethylene wear and osteolysis” again occurring, on average, within just 5 years of the patients’ index surgery.
Link to study: https://www.sciencedirect.com/science/article/pii/S2352344120300157
The patients included in the study showed signs of “catastrophic early polyethylene wear” seen on radiographs and “grossly visible and palpable wear” on the Exactech Connexion GXL acetabular liners. These liners were retrieved during revision surgery with acetabular cups and femoral stem components that were “clinically and radiographically well-fixed.” The authors of this study said this “unusual early excessive polyethylene wear” warranted “further investigation…to evaluate material characteristics which may have caused this accelerated wear.”
The authors of both studies contemplated potential design flaws of the Exactech Connexion GXL acetabular liners that may be causing these problems with early wear.