Australia’s TGA has issued hazard alerts for Microport Orthopedics metal-on-metal (MoM) hip implant components and Mathys Orthopaedics balanSys unicompartmental convex polyethylene inlays.
Patients with Microport Orthopedics MoM hip implants, most of them outside of Australia, are suffering possible tissue reactions to metal debris and need an increasing number of revisions. Affected implant components include the onserve resurfacing cup, dynasty metal liner, rim lock metal liner, and lineage metal liner.
There have been few users in Australia and the rate of revision there has been low, in part because these components have not been used in the country since 2013 and have been cancelled from the Australian Register of Therapeutic Goods.
The TGA also said that Mathys Orthopaedics is recalling some of its balanSys unicompartmental convex polyethylene inlays, which are used in knee replacement procedures, due to a higher-than-expected breakage rate.
There have been seven reports worldwide of these inlays breaking after about five years.