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ASR™ Articular Surface Replacement and ASR™ XL Acetabular System
Notice type:
Advisory
Date:
27/08/2010
Product name or type:
ASR™ Articular Surface Replacement and ASR™ XL Acetabular System
Reference:
IMB Safety Notice: SN2010(10
Manufacturer Or Supplier:
DePuy International Ltd
Target Audience:
Orthopaedic surgeons
Orthopaedic theatre staff
Orthopaedic registrars
Risk managers
Hospital CEOs
General Practitioners
Problem Or Issue:
Recall of DePuy’s ASR™ Hip Implant System due to higher than expected revision rate.
Background Information Or Related Documents:
On 26th August 2010, DePuy announced a worldwide recall of the ASR™ Hip System. This decision is based on new, unpublished data from the National Joint Registry (NJR) of England and Wales. The data shows the five year revision rate for the ASR™ Articular Surface Replacement is approximately 12% and for the ASR™ XL Acetabular System is approximately 13%. These revision rates are across the entire size range. The risk for revision was highest with ASR head sizes below 50 mm in diameter and among female patients.
DePuy circulated a field safety notice (FSN) on 26th August 2010 to advise customers of this recall. DePuy has advised the IMB that there is no stock currently held at Irish hospitals.
The Irish Medicines Board (IMB) is working with the HSE and orthopaedic surgeons regarding recommendations for patient review.
Patients who received the ASR™ XL Acetabular System or DePuy ASR™ Hip Resurfacing System will be contacted to schedule a review. However, if patients are experiencing pain, difficulty walking or other symptoms, they should contact their GP or orthopaedic consultant for advice.
ASR™ Articular Surface Replacement and ASR™ XL Acetabular System Document
Further Information:
All adverse incidents relating to a medical device should be reported to the:
Health Products Regulatory Authority
Kevin O’Malley House
Earlsfort Centre
Earlsfort Terrace
Dublin 2
Telephone: +353-1-6764971
Fax: +353-1-6344033
E-mail:
vigilance@imb.ie
Website:
www.hpra.ie
Enquiries should be addressed to:
Manufacturer:
DePuy International Ltd
St Anthony’s Road
Leeds LS11 8DT
England
Contact Person: Paul Arnott
Tel: 07771 971 930
Fax: 0113 387 6087
Email:
parnott@its.jnj.com
Please
click here
to download PDF version of the safety Notice
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Date Printed: 08/05/2024