The following article by Mark Hollmer at FierceMedicalDevices.Com reports how the Johnson & Johnson (Dupuy Orthopaedics) hip implant is being treated in courts and by regulatory agencies in the U.K, Australia and New Zealand. Read below.
Johnson & Johnson is facing more bad news over its metal-on-metal artificial hip implant products, this time in New Zealand and Australia.
Both countries’ regulatory agencies issued a recall of the MITCH TRH hip components made by J&J’s Finsbury Orthopaedics unit.
In New Zealand, the problem involves a loosening and movement of part of the joint. The warning notes that patients will need annual checkups as long as they have the implant, according to Radio New Zealand online. Some even may need a replacement, depending on what doctors find. In Australia, the country’s Register of Therapeutic Goods removed the MITCH TRH modular head from its listing, so it can no longer be used there, according to news.com.au. About 400 patients are affected by the Australian recall, and they’re being advised to ask their surgeon whether they need to have the device removed or just be closely monitored.
Earlier this month, the U.K.’s Medicines and Healthcare products Regulatory Agency issued a warning urging surgeons to stop using the MITCH TRH cup/heads, as well as the Accolade femoral stems made by Stryker that are intended for use with the MITCH TRH system. The warning takes into account an unusually high 10.7% revision rate for the product combo compared with rivals.
J&J is facing other metal-on-metal hip problems. Its DePuy Orthopaedics unit is one of many companies now facing lawsuits over apparent safety problems with a joint implant that faced a global recall in 2010. The FDA plans a two-day hearing in June to solicit risk-benefit data from manufacturers and others regarding the implants.