Stryker (NYSE:SYK) recently issued a safety notice involving its Star total ankle replacement in which it warned of higher than expected risk of polyethylene fracture.
The safety communication, dated Oct. 11, involved STAR total ankle replacements distributed before Aug. 1, 2014 — about the same time that Stryker acquired Small Bone Innovations and STAR (Scandinavian Total Ankle Replacement).
Stryker officials said they identified a 13.79% polyethylene fracture rate at the eight-year followup in the post-approval study for the device. They also found more than 100 polyethylene fractures reported in the FDA MDR database.
The rate of fracture problems was substantially more than other total ankle replacements and fixed-bearing total ankle replacements, according to Stryker.
Stryker included a reply form in the communication that it required hospitals and surgeons to return to acknowledge that they are aware of the problem, which can result in significant pain, inflammatory response, soft tissue injury and blistering, and more for people with damaged ankle replacements.
Stryker spokespeople could not be immediately reached for additional comment.