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

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DePuy Orthopaedics 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 in the U.S. prior to December 2005 are not affected by this recall.

call us for assistance
Rodrigo Diaz, Scientific Information Officer, is available to answer physician questions:
1-574-372-7401

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In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new, then-unpublished data from the National Joint Registry (NJR) for England and Wales as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip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.

The 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.

 
 
 

 

Dear Doctors and Hospital Representatives:

Thank you for your continuous support throughout the recall of the ASR™ XL Acetabular System and DePuy ASR™ Hip Resurfacing System. We would like your continued assistance with the reporting of revision surgeries.

To notify DePuy of a revision surgery, please call the ASR Retrieval Coordinator at 1-866-317-2556 or 1-574-372-7060.

Thank you again for your continued assistance. We appreciate your support. The ASR Retrieval Coordinator will contact you to follow up on your call, including instructions from patients, if any, related to the explanted components.

Court Order on Explants

 
 

 

 

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