DePuy ASR Revisions Up in New ZealandMar 27, 2012 | Parker Waichman LLP
Since DePuy Orthopaedics issued the ASR Hip Implant recall in August 2010, 23 percent of people in New Zealand who received the model used in total hip replacement have had it removed. Seven percent of those who received the DePuy ASR hip implant version used in hip resurfacing procedures in New Zealand have also had revisions, according to the country's hip registry.
According to a report on NZHerald, it's not clear exactly why the DePuy ASR Hip Implant revisions were ordered. Obviously, many of the hip implants failed prematurely. But NZ Orthopaedic Association president Bryan Thorn because of concerns sparked by the 2010 DePuy ASR hip implant recall, while others likely tested positive for elevated levels o chromium and cobalt in the blood.
DePuy Orthopaedics, a division of Johnson & Johnson, recalled the ASR XL Acetabular Hip Implant and the ASR Hip Resurfacing System were finally recalled in August 2010, after data from a medical device registry in the U.K. indicated that they were failing in about 12 of patients within five years. Worldwide 93,000 ASR devices were implanted, 507 in New Zealand, according to NZHerald.com.
A group of New Zealand patients is taking legal action in Britain against the manufacturer. Roughly 5,000 U.S. patients who received a DePuy ASR Hip Implant have filed lawsuits against DePuy and Johnson & Johnson. Most of the U.S. lawsuits are pending in a multidistrict litigation in Ohio.
Only the DePuy ASR Hip Implant used in total hip replacement procedures was sold in the U.S. The Food & Drug Administration (FDA) refused to approve the resurfacing device in 2009, citing troubling data from DePuy's clinical trials regarding high levels of metal ions in the blood of recipients, as well as higher reports of failures in patients overseas compared to what was seen in data submitted to the agency. Such problems weren't spotted by the FDA when it approved the ASR model used in traditional hip replacement, likely because that device was allowed to go through the less stringent 510(k) approval, which does not require human clinical trials.