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
The following physicians are available for questions:
Rodrigo Diaz, Scientific Information Officer:
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In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new, then-unpublished data from the National Joint Registry (NJR) of England and Wales as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip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 data showed a five-year revision rate of approximately 12% for the ASR Hip Resurfacing System and approximately 13% for the ASR XL Acetabular System, which was not in line with data previously reported to DePuy. These revision rates were across the entire size range.
DePuy’s previous analyses of collective post-market data from a variety of sources – including national joint registries, published literature, company-sponsored clinical trials, internal complaints data and external clinical research reports – had shown lower revision rates.
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.
Hip Implant Recall Information
DePuy ASR™ Hip Recall Resource Packet For surgeons and their office staff We appreciate that managing the ASR™ Hip System recall in your practice is a complex undertaking; this interactive PDF application will simplify your access to key information. This updated PDF recall guide compiles all the latest recall information in one place. Information contained within this recall guide includes:
|• Contact Information
||• Tracking Physician Admin Time
|• Notifying patients
||• Reimbursement for Patients
|• Patient Education and Claims
||• ASR™ Product Codes
|• Testing and Treatment Information
|• Explants and Revision Reporting
Click here or on the image above to open the Packet
The first ASR Recall Resource Packet was a printed guide published in November 2010. This comprehensive online guide replaces the earlier version and will be updated as information changes or new resources are added.
You may want to bookmark this page to ensure you’ll always have instant access to the most up-to-date information available.
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. As the recall efforts progress, we would like to ask your assistance with the reporting of revision surgeries using an online form (link below). This form provides a secure method of providing the necessary information to continue fulfilling our obligations to the federal government for medical device reporting (MDR). Please note that the HIPAA Privacy Rule permits disclosing protected health information, without a patient authorization, to a medical device company, for the purpose of medical device reporting. You can use this form to report pending or completed revision surgeries.
To notify DePuy of a revision surgery, simply click here
If at any time you have questions about the process for explanted components, please call the ASR Retrieval Coordinator at 1-866-230-9597.
Thank you again for your continued assistance with the ASR Recall efforts. We appreciate your support. The ASR Retrieval Coordinator will contact you to follow up on your submission, including instructions from patients, if any, related to the explanted components.