DePuy Hip Failure and Recall May Stem From Botched Approval Process

On July 17^th of last year the FDA issued a Class 2 medical implant recall for DePuy Orthopedics ARS hip implant. Specifically, the company’s notification to clinicians of new revision rate information regarding the use of the devices was cited as a reason for the DePuy hip replacement recall.  The DePuy hip recall involved 29 models of the ASR 100 and 300 Acetabular Implants in cup sizes ranging from 44mm to 70 mm. Between 2007 and 2009, reports of problems with the DePuy ASR hip system began to spike, with nearly 100 recipients reporting problems in 2007, more than 200 reporting problems in 2008, and more than 300 reporting problems in 2009. Last year, U.K. researchers studied 660 patients who had received metal hip implants from DePuy Orthopedics and found that 3.4 percent suffered from adverse reactions to metal debris. 

The ASR device was approved by the U.S. Food & Drug Administration (FDA) via the 510(K) process, which allows a manufacturer to obtain market approval with very little clinical testing of a device – including no human testing – if it is “substantially similar” to another product already on the market. The 510(k) approval process has received a great deal of criticism in recent years. In fact, shortly after the DePuy hip implant recall was issued, an internal FDA review found numerous flaws with the process. Just this past February, a study published in the Archives of Internal Medicine found that the majority of high risk medical device recalls over the past five years involved products subject to the streamlined 510(K) approval process.

Data from the National Joint Registry of England and Wales showed that 1 out of every 8 patients (12%-13%) who had received the devices had to undergo revision surgery within five years of receiving. The DePuy ASR Hip Resurfacing System was used in the U.K., but was not approved by for sale in the U.S. A number of individuals who have experienced problems with their DePuy metal hip are now reviewing the potential for DePuy ASR hip replacement lawsuits against the manufacturer, alleging that the hip implant was defectively designed and was sold with inadequate warnings about the risk of complications.