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The Artelon® CMC Spacer is a medical device used to treat osteoarthritis of the carpometacarpal joint of the thumb. The T-shaped device, made of a degradable polyurethane material called Artelon, is surgically implanted near the base of the thumb to help alleviate pain and give arthritis patients more mobility. The device was developed by Artimplant AB and marketed by Small Bone Innovations, Inc.
However, several reports of adverse events related to the Artelon CMC Spacer have been received by the Food and Drug Administration (FDA), including failure of this device. Problems reported to the FDA include foreign-body tissue reaction and implant rejection evidenced by redness, persistent pain, inflammation, reduced mobility and resultant bone loss/deterioration requiring revision surgery and/or removal of the device.
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