The Stryker STAR Ankle Replacement repairs ankle joints that have been compromised because of osteoarthritis, post-traumatic arthritis, or rheumatoid arthritis. In October 2019, however, Stryker Corp. warned that certain STAR Ankle Replacement patients should be closely monitored for broken bearings.
The Stryker STAR Ankle Replacement System is the first and only three-piece approved mobile bearing ankle implant available in the United States. STAR is an acronym for “Scandinavian Total Ankle Replacement,” as the system was developed by a well-known surgeon in Scandinavia.
The Stryker Star Ankle Replacement is made up of three parts:
Because the bearing is mobile rather than fixed, the Stryker STAR System is unlike any other ankle replacement system currently on the market. What’s more, bone cement is not needed to hold the components in place.
The ankle joint, also known as the tibiotalar joint, is where the shinbone (tibia) rests on top of the foot’s talus bone. When arthritis affects this joint, the smooth cartilage on the surface of the bones will wear away over time, resulting in pain, inflammation, and swelling.
Total ankle replacement was designed to replace a damaged tibiotalar joint and eliminate discomfort and swelling. During the procedure, a surgeon removes damaged sections of the tibia and talus bones. Artificial metal joints are then attached to the remaining bone surfaces, with a piece of plastic inserted between them.
While most total ankle replacements are very successful, some patients do experience complications, including:
Certain factors – including age, smoking, poorly controlled diabetes, and low bone density – can increase the risk of complications after total ankle replacement surgery.
For the first few weeks after surgery, most patients will require a splint and crutches. During the recovery period, they should let their doctor know right away if their pain increases or if they develop fever and chills.
On October 11, 2019, a Stryker Safety Communication warned that any patient with a STAR Ankle Systems distributed before August 2014 should be closely monitored for signs of a broken bearing.
Broken bearings may be the result of polyethylene oxidation, which can occur prior to or after implantation. Other factors that could contribute to this problem include component malalignment, surgeon learning curve, and reduced insert thickness.
Stryker issued the letter after identifying a 13.79% polyethylene fracture rate at the eight-year follow-up in a post-approval study. More than 100 reports of STAR Ankle Replacement polyethylene fractures had also been reported to the U.S. Food & Drug Administration.
Because the Stryker STAR Ankle Replacement System has shelf-life of about five years, these specific devices could have been implanted as recently as July 2019.
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