Artelon Spacer Lawsuit Lawyer
Please note: Our law firm no longer accepts Artelon cases.
Artelon spacer problems have been reported to the FDA by patients implanted with the CMC device. The reports concern patients’ adverse reaction or rejection of the Artelon spacer. Reported problems include persistent pain, inflammation and limited hand mobility. Artelon spacer problems have also led to bone loss and deterioration, requiring revision surgeries to remove the device and repair the damage it can cause.
If you or a loved one has experienced Artelon spacer problems, you may be entitled to financial compensation. Call or email us for a free legal consultation regarding an Artelon Spacer lawsuit. Please see our Testimonials.
Artelon Spacer Approval, History
The Artelon CMC spacer was merely cleared by the FDA in 2007 through the streamlined 510(K) process, and not approved through the Pre-Marketing Approval (PMA) process. The FDA’s “Indications for Use” reads: “Artelon CMC Spacer Arthro intended to be implanted into the first carpometacarpal joint (CMC-I) as an interpositional spacer between the trapezial bone and the first metacarpal bone. The device is intended to be used in thumb disabilities caused by osteoarthritis.” According to the manufacturer – Artimplant of Sweden – patients implanted with the thumb joint can expect joint stability, a quick recovery and minimal pain. Unfortunately, in addition to the FDA’s receiving several reports of Artelon spacer problems, recent medical studies have revealed the Artelon CMC Spacer is failing at a high rate.
Artelon spacer problems include:
Failing thumb joint
Inflammation and swelling
Limited range of motion
If you or someone you love is experiencing Artelon spacer issues, contact an Artelon attorney now for a free legal consultation.
Some patients suffering from Artelon spacer problems have required painful revision surgeries to remove the implant. Some patients have reported the Artelon CMC Spacer breaking apart in the hand, requiring immediate second surgery. Those cases require surgeons to extract tendons from other parts of the body to repair the thumb joint.