FDA is advising patients, caregivers and healthcare providers about a higher than expected risk of breakage of the polyethylene component of the STAR ankle replacement, as early as three to four years after implantation. Fracture of the component may lead to surgery to repair or replace the device.
Based on FDA’s analysis of FDA-required post-approval studies and adverse event reports, the potential risk may exist for all STAR Ankle devices, regardless of the date of manufacture or distribution.
FDA believes that the STAR Ankle remains appropriate for certain patient populations, such as older patients with lower activity levels. The agency is not recommending removal of any implants at this time.
STAR is indicated for use as a non-cemented total ankle prosthetic to replace a painful arthritic ankle joint due to osteoarthritis, post-traumatic arthritis or rheumatoid arthritis. The system was acquired from Stryker by DJO in 4Q20.
For Colfax Corporation, DJO's parent company, the acquisition represented a key component of its growth strategy in the lucrative foot and ankle market. The company estimates the market opportunity at $1 billion, with a highly fragmented competitive landscape ripe for further acquisitions.
The device was approved in the Premarket Approval application in 2009, with two post-approval studies required by FDA.
After the STAR ankle purchase, Colfax CEO Matt Trerotola said, "When we were doing the planning for the acquisition of DJO, we looked at whether there were attractive adjacencies. Foot and ankle was one that had attractive growth, good structure and good possibilities. It was a nice surprise to have the Stryker transaction create this opportunity this early in our ownership of DJO to step into that adjacency at an attractive price."