DePuy ASR™ Hip Implant Recall Guide

guide for patients
The patient guide helps patients determine if they’re affected by the ASR Hip System recall and learn more about testing and treatment.

Patient hip recall information

DePuy issued a voluntary recall of its ASR™ XL Acetabular Hip System and DePuy ASR™ Hip Resurfacing System in August 2010. This guide is intended to support your evaluation and continued care of patients affected by the recall and to help you answer patient questions. We appreciate your assistance in providing ASR hip implant recipients and your organization with important information about this recall. Patients who had hip surgery prior to July 2003 are not affected by this recall.

call us for assistance
Should you have any outstanding questions please contact the ASR Help Line on 0800 2794865 or 01908 302 195. Lines are open from 09.00 – 17.00, Monday to Friday.

DePuy Recall Information

In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new, then-unpublished data from the National Joint Registry (NJR) for England and Wales as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip System. After reviewing this data, DePuy decided it was in the best interests of patients to voluntarily recall the ASR Hip System.

This 2010 UK data showed a five-year revision rate of approximately 12 percent for the DePuy ASR Hip Resurfacing System and approximately 13 percent for the ASR XL Acetabular System, which was not in line with data previously reported in that registry. These revision rates were across the entire size range.

Before summer of 2010, the totality of the data available to the company showed ASR was performing consistent with the class of monoblock metal-on-metal hip implants.

Note: The DePuy ASR™ Hip Resurfacing System was only approved for use outside the U.S. and the ASR™ XL Acetabular System was available worldwide.

 
 
 

For more detailed information about treatment for ASR hip implant recipients, DePuy’s coverage of treatment costs and why these products were recalled, please use the resources listed below. If you have additional questions, we are available to speak at your convenience using the contact information located above.

Recall Notice

Metal Ion, Radiological and Cross-Sectional Testing Protocols

Patient Process Flow

HCP Process Flow

Medical Admin Patient Data Report

Blood Sampling And Shipping Protocol

Surgeon Confirmation for ASR Revision

Medical Admin Reimbursement Time

 
 
 

Our continued goal is to help you answer your patients’ questions and support their prompt follow up care and treatment. Therefore, our ongoing recommendation is that you contact your patients and request that they schedule a follow up appointment for evaluation as soon as possible. We would encourage all surgeons who have patients affected by the ASR recall to follow thorough and complete diagnosis outlined in the below Metal Ion, Radiological and Cross-Sectional Testing Protocols document.

We have created the following resources to help you address your patients’ needs, including downloadable, easy to understand information sheets you can provide to patients who may have questions or concerns.

Sample Letter for Surgeons to Send to ASR Patients 

Patient Consent Form

Patient Consent Form – Additional Information

Metal Ion, Radiological and Cross-Sectional Testing Protocol

 
 
 
Country Region: 
Do not include in the landing page