March 6, 2010—DePuy Orthopaedics, a subsidiary of Johnson & Johnson, announced its ASR hip replacement device was associated with high failure rates in some patients.
The announcement comes more than two years after reports first emerged questioning the safety of the devices. Sales of the DePuy ASR devices in Australia were halted in December 2009 due to safety concerns.
A letter to doctors sent on March 6, 2010 indicated that the DePuy ASR hip device had a higher-than-expected failure rate in certain patients, particularly women and people with weak bones.
The ASR device is a metal-on-metal hip replacement system. These implants are under increasing scrutiny because they generate large amounts of metallic debris over time. The wear can require an operation to remove the device and can cause damage to muscles and other soft tissues.
The DePuy ASR hip device was approved by the FDA in 2005 under a process that did not require it to undergo clinical safety trials. The FDA has received approximately 300 reports of failure since 2008. The majority of those individuals required an expensive and painful operation to remove the device.