High Failure Rate Among Patients with Metal-on-Metal DePuy-Stryker Hip Implant Prompt's Warning in U.K.Apr 4, 2012 | Parker Waichman LLP
Calling its failure rate "unacceptably high," regulators in the U.K. yesterday warned doctors there against using certain metal-on-metal hip implant components, Mitch TRH cup/heads, in combination with Stryker Orthopaedics’ Accolade Femoral Stems. According to a notice from the Medicines and Healthcare products Regulatory Agency (MHRA), data from the national joint registry for England and Wales indicated that the device combo will fail and require revision surgery in more than 10 percent of patients only four years after implantation.
The Mitch TRH system is a metal-on-metal hip replacement system consisting of components that can be used in different combinations to carry out either hip resurfacing arthroplasty or total hip replacement. The components were Finsbury Orthopaedics Ltd., which was purchased DePuy Orthopaedics, a unit of Johnson & Johnson, in 2009. The Mitch TRH system was distributed in the U.K. by Stryker between May 2006 and October 2011.
“Analysis has shown that the revision rate for this combination of implant is unacceptably high. This is why we have advised surgeons to stop using this combination and to monitor their patients closely," Dr Susanne Ludgate, clinical director of the MHRA, said in a statement.
Some 270 people in England and Wales have this combination of hip components, according to the MHRA. Those patients should be closely monitored, the agency said.
The U.K. warning only applied to patients who have received the components in total hip replacement, not hip resurfacing procedures.