Johnson & Johnson Withdraws Hip Device

DePuy, a unit of Johnson & Johnson, has announced that it has warned doctors that its artificial hip device known as ASR has a higher early failure rate in some patients. Months before this latest announcement, DePuy had said it planned to phase out the ASR hip device due to poor sales.
ASR is a metal on metal artificial hip device that has shown an early failure rate that has led to painful and complicated revision surgery in some hip replacement patients. DePuy officials have disputed the safety issues although an Australian doctor, Dr. Stephen Graves, found that data has shown for some time that the ASR has a higher early failure rate than those of ASR’s competitors. Dr. Graves is the director of an implant database in Australia. ASR was removed from the Australian marketplace in December 2009. Graves and other physicians have criticized DePuy for its failure to remove the hip device sooner.
According to the NY Times, DePuy officials cited poor sales figures for the phase out of ASR in spite of Dr. Graves’ contention that there are safety issues with the artificial hip.
“With declining sales of this particular product in its market segment, we are focusing on newer technologies,” Sally Hunter, DePuy’s worldwide vice president for regulatory affairs, said last month.
The Times reports that the FDA has received 300 complaints from ASR patients since the beginning of 2008. The majority of those patients have undergone a revision surgery to replace the failed ASR hip with a new hip device.
Some orthopedic surgeons, including the ASR’s co-developer, Dr. Thomas P. Schmalzreid, have admitted to issues with the ASR device. “The window for component position that is consistent for good, long-term clinical function is smaller for the ASR,” stated Schmalzreid. When notified of Dr. Schmalzreid’s comments concerning ASR, DePuy officials expressed surprise.
The problems to which Dr. Schmalzreid was referring concerning the positioning and placement of the cup.
DePuy is not the only artificial hip device manufacturer to experience safety problems in the past few years. Stryker Corp. and Zimmer Holdings Inc. have had design defect issues that have led to hip recalls or the suspension of sales of these products.