1205 East Washington Street | Suite 111 | Louisville, KY | 40206

Exactech Hip Implant Recall: Do you have a legal claim?

What Is An Exactech Connexion GXL Hip Liner And How Does It Work?

The Exactech Connexion GXL hip liner is a special liner that is intended to be implanted as part of an complete hip replacement system into patients requiring a total hip replacement surgery. A hip liner is typically made of plastic or ceramic materials and is inserted between the patient’s acetabular cup and the ball joint (femoral head). In order to recreate a hip joint, implants usually have a ball joint that fits in a cup called an acetabular component. The acetabular component is usually comprised of an acetabular shell or “cup” and a liner. This ball joint and acetabular shell come together and fit within the hip socket. The liner is designed to fit in between the ball joint and the acetabular shell thus Cushing the contact between the two parts and allowing the hip joint to rotate and move freely within the cup. Exactech markets the Connexion GXL Liner as more resistant to wear and fracture based on special manufacturing process it uses to create its liner. Exactech uses irradiated ultra-high molecular weight polyethylene (UHMWPE)  plastic to construct the liners, the company claims that this special radiation process makes the liners more resistant to wear and fractures over time.

Exactech GLX Hip Liner Recall

On July 22, 2021, Exactech recalled various models of the GXL hip liners for a “risk of edge-loading and premature prothesis wear [being] possible in a specific subset of patients with certain implant configurations and surgical implant positioning.”(*1) Medical complications that can occur with GXL hip liners include but are not limited to: (1) pain, (2) stiffness, (3) loosening, (4) difficulty with mobility,  (5) joint weakness and (6) osteolysis (degeneration of bone tissue). All if these potential medical complications may result with patient implanted with A GXL hip liner having to undergo a revision surgery to fix the defect in the liner and hopefully alleviate the complications resulting from the defective hip liner.

High Rate of Early Failure

Two separate studies published in 2020 regarding the Exactech Connexion GXL liner found that the liner may be prone to a high rate of early failure. Dr. W. Christian and colleagues at the University of Florida College of Medicine published findings in the Journal of Arthroplasty (*2) which looked at their institutional databases for patients that had significant osteolysis after having had a primary hip replacement that included a GXL Liner. The study looked at patients implanted with the GXL liner from January 2009 to June 2019 and found a total of 12 patients that had actually had the GXL liner implanted into their bodies. Out of the 12 patients, 9 patients had undergone a revision surgery due to medical complications related to the GXL liner. The study found the average time before the implant failed was 55.9 months or approximately  5 years, which is an uncommonly short time for a normal total hip replacement to require a revision surgery. The authors of the study concluded that “the Exactech Connexion GXL Liner may be prone to a higher rate of early failure from wear and severe secondary osteolysis” the authors of the study recommended close observation of patients implanted with the GXL liner.

Another study conducted by Dr. Cynthia Kahlenberg and colleagues at the Hospital for Special Surgery in New York was published in Arthroplasty Today (*3). In the study, 204 total hip replacements performed by one surgeon involving the Exactech Connexion GXL liner were examined. The study found 5 cases of catastrophic early polyethylene wear that occurred within 5 years of initial surgery,  demonstrating  a concerning failure trend with the use of the GXL liner.  All 5 patients reported having hip pain that resulted in the need for revision surgeries. MRI’s and x-rays taken from each of the 5 patients confirmed early wear and osteolysis in patient’s hip joints.  This separate study also recommended further investigation of the Exactech Connexion GXL liner citing potential design flaws in the GXL Liner that could possibly be causing problems with premature wear and osteolysis in patients.

FDA Adverse Events Reported

The U.S. Food and Drug Administrations (FDA) maintains a databases of adverse events for medical devices called the Manufacturer and User Facility Device Experience (MAUDE). A review of the database for Exactech Connecxion GXL liners reports found 83 adverse reports which resulted in patients with the GXL liners having to undergo revision surgeries. 22 of these adverse reports specially noted the patients requiring a revision surgery due to “poly wear” or “osteolysis”. After reviewing all 83 adverse reports relating to the GXL liner it was found that the average time between the initial implantation surgery and the revision surgery for the GXL Liner was approximately 6.5 years, far less then the expected lifespan of the liner.

Free Exactech Connexion GXL Liner Consultation

            If you or a loved one was implanted with an Exactech Connexion GXL Liner as a component of your hip and have suffered pain, stiffness, loosening, difficulty with mobility or walking, joint weakness and or osteolysis as a result of the implant please contact the attorneys at JONES WARD PLC for a free case evaluation. We can discuss whether you or your loved one has a potential claim against Exactech. Call us toll free today at 888-595-2922.

 

Sources.

 

(*1) https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm?start_search=1&event_id=88126&productdescriptiontxt=&productcode=&IVDProducts=&rootCauseText=&recallstatus=&centerclassificationtypetext=&recallnumber=&postdatefrom=&postdateto=&productshortreasontxt=&firmlegalnam=&PMA_510K_Num=&pnumber=&knumber=&PAGENUM=100

 

(*2)

https://www.sciencedirect.com/science/article/abs/pii/S0883540319311921

(*3)

https://www.sciencedirect.com/science/article/pii/S2352344120300157

Leave a comment