The Artelon Spacer is a medical device marketed by Small Bone Innovations, Inc. The device is used by those suffering with arthritis with the objective of resurfacing and stabilizing the osteoarthritic trapeziometacarpal joint (found in the hand). The Artelon Spacer has been linked to problems in patients including foreign-body tissue reactions and rejections. The Spacer must be surgically implanted in patients meaning any adverse side effects typically require additional surgical procedures.
The Artelon Spacer is used to treat patients suffering from arthritic conditions, namely osteoarthritis of the carpometacarpal joint of the thumb. The manufacturer targets those experiencing pain in picking up objects, trouble holding objects or difficulty turning keys or doorknobs. Artelon Spacer patients endure a surgical procedure whereby a degradable spacer is implanted at the base of the thumb. The procedure is typically outpatient and the Spacer is absorbed by the body over time and provides a framework for the body to produce new tissue growth to restore the thumb’s functionality.
Problems reported with the Artelon Spacer range from reduced mobility to complete foreign-body tissue rejection. Many patients have endured painful follow-up surgeries to remove the implant after symptoms persisted. Symptoms of Artelon Spacer rejection include burning, inflammation, swelling, misshapenness of the thumb, limited range of motion and deterioration of the hand bones. Many patients had their Spacers removed after the device broke apart in the hand requiring the surgeon to supplant extra tendons from other parts of the body to reconstruct the thumb joint.
In April, 2011, mass tort litigation commenced in Philadelphia, Pennsylvania for those plaintiffs suffering from injuries stemming from Artelon Spacers. Plaintiffs’ complaints are congruent with the numerous adverse event reports received by the FDA over the past several years.