Australian Regulatory Authorities Issue Caution Warning About Arthroplasty Device

LMT Surgical Pty. Ltd., a surgical product and orthopedic device maker based in Australia, has issued a hazard alert in Australia for all sizes and lots of its Pyrotitan humeral resurfacing arthroplasty device. The alert was released in consultation with the Therapeutic Goods Association (TGA), an Australian governmental agency similar to the U.S. Food and Drug Administration. The TGA falls under Australia’s Department of Health and Ageing. A hazard alert is information issued to healthcare professionals about issues or deficiencies relating to an implanted medical device or biological product and advice about the ongoing management of patients. At this time, the devices have not been recalled.

The Pyrotitan humeral resurfacing system is intended to address glenohumeral joint disease due to non-inflammatory, inflammatory and post traumatic arthritis by replacing the damaged humeral head bearing surface and restoring patient anatomy while preserving bone.

According to LMT, Pyrotitan humeral resurfacing arthroplasty devices have been identified as having the potential to break after being implanted. If this occurs, revision surgery will be necessary. In most confirmed cases, breakage has occurred within a year of the device being implanted and has been the result of excessive loads being put on the device. Excessive loads may occur during high impact activities (such as hammering; free weights; and contact sports, such as football) or as a result of sudden trauma. Implant breakage can result in glenohumeral joint pain and possible damage to the surrounding tissue. LMT self-reported that 3 percent of implanted devices worldwide have experienced breakage. Two of the devices returned to the manufacturer for examination have been found to have sub-surface fractures, which is believed to have contributed to the high rate of breakage.

LMT Surgical has written to surgeons who have implanted Pyrotitan humeral resurfacing arthroplasty devices, providing further information about the above issue and advice on how to treat affected patients. However, the company has not released the contents of this advisory letter to the public.

Pyrotitan in the United States

The Pyrotitan device was introduced in the United States in May 2010 by Ascension Orthopedics Inc., which has since been acquired by Integra LifeSciences Holdings Corporation. At the time of release, the device was touted as the “first commercially-available, human shoulder arthroplasty prosthesis made of Pyrocarbon.” Pyrocarbon is the commercial name for pyrolytic carbon, is a material similar to graphite, popular for orthopedic implants because of its resistance to wear and biocompatibility with native cartilage and bone.

Now styled Integra Titan in the United States, the device is still on the market with no indicaton from either Integra or the FDA that it poses a danger to patients.

Integra officials declined to comment.