A recall has been issued for the Exactech Connexion GXL acetabular liner in hip replacements by the device manufacturer, Exactech Inc. Early failure of the liner as a result of wear and tear means patients who had the liner implanted during primary or revision surgery may require additional medical procedures to repair damages caused by this defective medical device.
In issuing the recall, Exactech Inc. stated a “Risk of edge-loading and premature prosthesis wear is possible in a specific subset of patients with certain implant configurations and surgical implant positioning.”
The company reports defective packaging may allow oxygen and other environmental contamination to degrade a key plastic component prior to implantation. Resulting oxidation can cause the plastic to prematurely wear or become damaged after implantation into the patient’s body.
A study by the Department of Orthopedics and Rehabilitation at the University of Florida College of Medicine found that the Exactech hip liner suffers early failure in some patients. Doctors studied patients who required revision surgery after having a complete hip replacement using Exactech Connexion GXL acetabular liners between 2009 and 2019.
A review of the database maintained by the Food and Drug Administration revealed more than 25 percent of reporting patients who required revision surgery needed the procedure because of “plastic wear” or “osteolysis” bone loss caused by plastic wear that resulted in friction between metal components. The length of time between the initial hip replacement and the revision surgery was just 6.5 years.
“The Exactech Connexion GXL liner may be prone to a high rate of early failure from wear and severe secondary osteolysis. We recommend close surveillance of patients with this bearing surface,” the authors wrote.
The hip liner is inserted into the leg of a patient during complete hip replacement. The job of the liner is to allow the metal or ceramic components of the artificial hip to move freely.
Exactech issued an “Urgent Medical Device Correction” notice in July 2021, impacting the more than 89,000 devices distributed in the United States.
Claims for Defective Hip Implants in Colorado
As part of the recall, Exactech has set up a claims procedure to reimburse for out-of-pocket expenses and has hired a third-party administrator to handle the process. But the reality is the company process will likely do little to compensate patients suffering from pain, discomfort, loss of mobility, and the need for revision surgery or other medical procedures. Of additional concern is the fact that the company’s solution is to replace part of the implant, which could further complicate long-term reliability.
An experienced defective medical device attorney in Colorado will be in the best position to advise clients of their options while moving to recover compensation for all of the damages to which they are entitled.
The McLaughlin Law Firm has what it takes to manage the key details, evidence, and proceedings to set these cases up for success. The steps we take to strengthen medical device injury cases and position them for favorable outcomes include conducting a thorough examination, preservation of evidence, use of qualified legal and medical experts, and comprehensive pretrial negotiations that are backed by extensive case preparation and a long track record of success in the courtroom.
If you are suffering from surgical complications or issues related to a defective hip implant, please call the McLaughlin Law Firm at (720) 463-1516 for a free and confidential consultation to discuss your rights.