Artelon® CMC Spacer Complications Reported to FDA

The U.S. Food & Drug Administration (FDA) has received a number of adverse event reports involving a thumb joint implant called the <"">Artelon® CMC Spacer. In some of these cases, patients have had to undergo additional surgeries when an Artelon® CMC Spacer failed.

The Artelon® CMC Spacer was brought to market three years ago, and is used to treat individuals suffering from early to mid stage osteoarthritis of the carpometacarpal joint of the thumb. The devices consists of a t-shaped piece of plastic gauze that is supposed to be both biocompatible and degradable. During outpatient hand surgery, the Artelon® CMC Spacer is implanted near the base of the thumb, in the first carpometacarpal joint near the wrist joint.

According to a press release issued in 2007 announcing the device’s FDA approval, the Artelon® CMC Spacer allows surgeons to avoid violation of the joint capsule, which in turn provides for maintenance of joint stability, faster recovery and less pain.

Unfortunately, some patients have experienced serious complications after having this device implanted. In some cases, the thumbs of patients have become visibly misshapen following implantation of the Artelon® CMC Spacer. Some patients have experienced an inflammatory response and swelling with bone loss. In other cases, the Artelon® CMC Spacer has broken apart while still in the hand.

When the Artelon® CMC Spacer fails in this manner, it needs to be removed. Such additional surgeries may require the removal of tendons from other areas of the body, such as the arm, to fully repair the thumb joint.

Signs that an Artelon® CMC Spacer has failed include pain, inflammation, limited range of motion, redness near the implant, or a misshapen thumb. Anyone with this implant should immediately seek medical attention if they experience any of these problems.

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