Home arrow Depuy ASR Hip Recall arrow Medical Device Alert: DePuy ASR acetabular cups used in hip resurfacing arthroplasty and total hip r
Medical Device Alert: DePuy ASR acetabular cups used in hip resurfacing arthroplasty and total hip r

Medical Device Alert: DePuy ASR acetabular cups used in hip resurfacing arthroplasty and total hip replacement

The MHRA has received reports of higher than anticipated rates of revision for ASRTM acetabular cups.


Subsequent to the publication of the MHRA’s Medical Device Alert MDA/2010/033 for metal-on-metal hip replacements on 22 April 2010, the National Joint Registry (NJR) of England and Wales informed the MHRA that ASRTM acetabular cups had been identified from registry data as having higher than anticipated rates of revision in hip resurfacing and total hip replacement procedures (see Appendix). The MHRA has also received similar reports from two of the 257 clinical centres in the UK that have implanted these devices.

 

depuy_asr_hip_lawyers_wat.jpgDePuy produces two different instruction documents for this device: the instructions for use (IFU) supplied with the device, and the surgical technique manual. A cup inclination angle of 45º is recommended for reaming and implantation in all versions of the surgical technique manual. However, the original IFU did not contain reference to specific cup placement angles. Based on post-market experience, in October 2008, the manufacturer added to its IFU (Revision C) a recommended cup inclination angle of between 40º and 45º and distributed a document entitled ‘The importance of correct acetabular component positioning’ highlighting the importance of cup angles to implanting surgeons from February 2009.

 

All users were informed of correct cup angles in the manufacturer’s Field Safety Notice of 8 March 2010. The FSN did not recommend any additional follow-up for patients in the absence of symptoms. However, the performance of devices implanted outside the manufacturer’s currently recommended angle range (40º– 45º) is not known.

DePuy ASRTM acetabular cups have been in clinical use in the UK since 2003.

Source: http://www.orthospinenews.com/medical-device-alert-depuy-asr-acetabular-cups-used-in-hip-resurfacing-arthroplasty-and-total-hip-replacement 

 

To monitor whether or not a DePuy ASR Recall has occurred or not, please click the link to visit the page.


If you or a loved one has been implanted with a DePuy ASR System and required revision surgery or other complications please contact us for a free claim evaluation.

CALL NOW 1-866-374-0338

 


Get your free, no obligation claim review by a lawyer today.

  • Call us at toll free 1-866-374-0338, or
  • use the Free Claim Evaluation form to your right, or
  • click on Live Support on the right of this page.

We have represented clients in every state and helped thousands of injured clients nationwide make recoveries for their injuries. We are ready to help you! Our clients are never at risk of paying any fees, expenses, or costs out of pocket. All fees costs and expenses are paid only out of any recovery we make for you.


Do not delay. Contact us now to find out if we can help. The claim evaluation is free. All claims have strict time limitations which will bar any recovery you or your loved may be entitled if the claim is not brought on time.

CALL NOW 1-866-374-0338

.

 

Testimonials

Free Case Review

First Name (*)
Invalid Input
Last Name (*)
Invalid Input
Email (*)
Invalid Input
Best Call Back Time (*)
Invalid Input
Zip Code (*)
Invalid Input
State (*)
Invalid Input
Street (*)
Invalid Input
Phone (*)
Invalid Input
Date of Implant (*)
Invalid Input
Info. About Your Case (*)
Invalid Input


By submitting this form I agree to the following disclaimer. (*)

Invalid Input
Enter the numbers as they are shown in the image below.
Enter the numbers as they are shown in the image below.Refresh Invalid Input