The STAR Ankle has early poly fracture issues, so the FDA issued a warning (scrolll down for FDA statement).
How does this happen?
I worked for a device company that tried to acquire the STAR Ankle in 2005. I learned that the STAR was a very dated design. Ultimately, Small Bones Innovations acquired the ankle, then Stryker acquired SBI.
Dr. Hakon Kofoed in collaboration with LINK AG designed the implant back in 1981 as a fixed bearing version. The "modern" STAR Ankle (generation 4) was designed in 1998. There are 23 years of clinical results and counting for the new STAR Ankle, and 40 years of clinical history for the original generation 1.
So I ask again. How does this happen?
Something is broken in our system.
FDA warns plastic component could break in all of Stryker’s STAR ankles (MassDevice)
The FDA today issued a warning regarding the STAR ankle previously made by Stryker (NYSE:SYK) — and the potential for a fracture of the plastic component.
According to an FDA news release, there is a higher-than-expected risk of the polyethylene (plastic) component of the device breaking as early as three to four years after implantation of the STAR (Scandinavi...
