ASR™ Hip System recall guide
for healthcare professionals

last updated 6 December 2010

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 organisation with important information about this recall.

Patients who had hip surgery in Malaysia prior to March 2006 are not affected by this recall.

call us for assistance
The following physician is available for questions:

Dr. John Flores: Tel: +65 6827 6032

To register a patient for treatment and reimbursement, call the ASR Help Line on 1800 806 545. The call center will be active from 9.00 am – 5.30 pm, 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In August 2010, DePuy issued a voluntary recall of the ASR Hip System after receiving new, then-unpublished data from the National Joint Registry (NJR) for England and Wales as part of the company’s ongoing surveillance of post-market data concerning the ASR Hip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 and the ASR™ XL Acetabular System became available in March from March 2006.

 
 
 

We appreciate that managing the ASR™ Hip System recall in your practice is a complex undertaking, please refer to the resources below for key information

Recall Notice

Guidance on X-Ray, MRI and Ultrasound Testing

ASR Recall Blood Sampling and Shipment Protocol

If you have questions, we are available to speak at your convenience using the contact information located above.

Please note: DePuy does not maintain a list of patients who received an ASR Hip and the ASR Help Line will not be able to confirm to patients whether they have received an ASR implant. Patients who do not have copies of their medical records will need to consult with their surgeon, hospital or family physician to confirm the details of their implant or request that the ASR Help Line contact their surgeon on their behalf. Surgeons will need to complete a reimbursement checklist that confirms their patient’s hip implant and surgery details.

 
 
 

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.

Patient Consent Form

Additional information about the Patient Consent Form

ASR Patient Handout on Claims and Reimbursement Process

Sample Letter for Surgeons to Send to ASR Patients

Sample Letter for Surgeons to Send to Non ASR Patients

 
 
 
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