DePuy Recalls ASR Hip System

Due to the number of patients who have required revision surgery, DePuy (Warsaw, IN) has issued a voluntary recall of its ASR XL acetabular system and its ASR hip resurfacing system. “We regret that this recall will be concerning for patients, their family members and surgeons,” says David Floyd, president, DePuy Orthopaedics.  “We are committed to assisting patients and health care providers by providing information through multiple channels and paying for the cost of doctor visits, tests, and procedures associated with the recall.” The ASR device was discontinued in 2009. 

Unpublished 2010 data from the National Joint Registry of England and Wales reveals a five-year revision rate of nearly 12% for the ASR hip resurfacing system and about 13% for the ASR XL acetabular system. According to DePuy, the revision rates are the entire size range, but the revision risk was highest with ASR head sizes below 50 mm in diameter and among female patients. 

In a statement, DePuy said that it intends to cover "reasonable and customary costs of monitoring and treatment for services, including revision surgeries, associated with the recall of ASR." The company has also noted that most ASR hip replacement surgeries have been successful, but it is still advising patients who have the device to visit their surgeons for an implant performance evaluation. DePuy recommends yearly monitoring of the device to ensure that it is functioning, even when patients are not experiencing symptoms that could indicate otherwise.