The STAR Ankle is a total ankle replacement, or “prosthetic joint,” that is manufactured by Stryker. It is used in patients with painful ankles due to arthritis, osteoarthritis, or rheumatoid arthritis.

On March 15, the FDA issued a Safety Communication to warn patients about the higher-than-expected risk of a plastic part breaking on all Scandinavian Total Ankle Replacements (“STAR Ankles”).

Some of the artificial ankle joins fractured as early as 3 to 4 years after implantation, according to the FDA. If this occurs, patients may need another surgery to repair or replace a broken STAR Ankle.

The problems were discovered during an safety study that the FDA ordered the manufacturer to complete when the STAR Ankle was approved in 2009.

The study found a 13.8% fracture rate in the plastic component (12 out of 87 patients) at 8 years post-implantation, with all twelve patients requiring another surgery.

The FDA believes the risk may actually be higher, due to doctors having difficulty diagnosing a fracture because it is hard to see broken plastic parts on a CT scan.

Furthermore, the FDA said it has received about 300 adverse reports of fractured plastic components since 2009, and found another 72 fractures in patients who had surgery to remove their STAR Ankle.

Some patients may also face a higher risk of a broken STAR Ankle Replacement, according to the FDA warning.

High-risk patients include those with osteoarthritis, more active lifestyles, age under 55 years old, and thinner (6-mm) plastic components in their implant.

Source: Risk of Device Component Breaking in Patients with Stryker’s STAR Ankle: FDA Safety Communication

Posted by Daily Hornet

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