FDA Warns of High Rate of Stryker STAR Ankle Implants Breaking

Federal health officials have issued new warnings about the risk of Stryker STAR Ankle replacements problems, indicating the implants have an unexpectedly high risk of fracturing, resulting in significant pain, loss of mobility and the need for revision or replacement surgery.

The FDA issued a Stryker STAR Ankle replacement warning on March 15, following a review of data from a post-approval study which found more than 300 reports of the device’s plastic components breaking or degrading as early as three to four years after an ankle replacement.

The devices are used to repair ankle joints which have been compromised and cause consistent pain, usually due to the development of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. By replacing the ankle joint and allowing motion to occur, the procedure is intended to increase mobility and provide an alternative for patients living with pain or taking medications to provide joint pain relief.

Concerns surrounding Stryker Star Ankle Replacements breaking were first raised in 2019, after the manufacturer released a Safety Communication that disclosed more than 100 reported implant fractures. At the time, the manufacturer indicated the problems may be due to increases in polyethylene oxidation, prior to or after implantation. Additional scenarios leading to the reported device fractures include component malalignment, surgeon learning curve, and reduced insert thickness.

While the devices were granted Premarket Approval (PMA) by the FDA in May 2009, the agency required Stryker to conduct two post-approval studies to examine the performance and adverse event reports.

This latest Stryker Star Ankle Replacement warning comes in the wake of the FDA’s analysis of the required post approval studies, which identified at least 1,841 adverse event reports, including 300 fractures. By the eight year mark of the post approval study, the fracture rate of the plastic components was 13.8%, with all fractures requiring surgical intervention to remove or replace the device.

Of the 300 events resulting in surgical intervention, 244 implants required removal. The studies indicate 72 devices experienced plastic component fractures while the majority showed signs of material oxidation degradation causing loss of mobility after three to four years of implantation.

According to the warning, the FDA stated the long-term rates of Stryker STAR ankle implants breaking are unknown, and healthcare providers and patients should be cautious of several attributing factors including component thickness, material degradation and patient factors.

The warning indicates younger, and more active patients with high activity levels could be subject to an increased risk of fracture and should be closely monitored.

Symptoms of Stryker STAR ankle replacement degradation or fracture may include increased pain, inability to bear weight on the ankle, the onset of grinding or other noises in the operated ankle, or worsening instability in the replaced ankle. Patients who have experienced a significant fracture may experience severe pain, inflammation, soft tissue injuries and blistering, loss of mobility in the ankle, and possible damage to the metal components in the ankle requiring total ankle replacement.

The FDA urges doctors and patients who suspect or experience problems with the Stryker STAR Ankle Replacement devices to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.