LMT Surgical issues hazard alert for humeral resurfacing device

LMT Surgical, in consultation with the Australian Government Therapeutic Goods Administration, has issued a hazard alert for all sizes and lots of the firm’s PyroTitan humeral resurfacing arthroplasty device.

There is a potential for the devices to break after implantation. If this occurs, revision surgery will be necessary. LMT Surgical has contacted orthopaedic surgeons who implanted this device in writing to provide them with information about this issue and with advice on how treat affected patients, according to the alert.

“This hazard alert is being undertaken because 3% 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,” TGA officials wrote in the alert. “Future supply of PyroTitan humeral resurfacing arthroplasty devices in Australia will not occur before appropriate corrective actions have been implemented,” which should take several months to complete.

Orthopaedic surgeons should check the Therapeutic Goods Administration website for a list of the parts and lots affected.

In most of the confirmed cases that were reported, breakage occurred within a year of the device being implanted and the breakage was attributed in the alert to excessive loads being put on the device. Such excessive loads may occur as the result of a sudden trauma, particularly when patients have poor bone stock, or during high impact activities, such as hammering, use free weights or during contact sports. High impact activity may cause loosening or fracture of the device. A breakage can result in glenohumeral joint pain and possible damage to the surrounding tissue, as noted in the alert.

Reference:

http://www.tga.gov.au/safety/alerts-device-pyrotitan-130812.htm