Sunday, November 14, 2010

Key Facts from the DePuy web site

Key Facts from the DePuy web site:
Which Hips have been recalled?
The Recalls involve two products post 2003:
·         The ASR XL Acetabular System
·         The ASR Hip Resurfacing System.  (This one was never approved in the US and was only sold outside the country.)
Symptoms
The patients who reported problems in the first five years and had revision surgery reported a variety of symptoms. These symptoms included pain, swelling and problems walking. These symptoms are normal if you have just had a hip replacement. If the symptoms continue or come back, it is a sign that there may be a problem.
Causes
The symptoms above might be caused by problems such as:
· Loosening – when the implant does not stay attached to the bone in the correct position
· Fracture – where the bone around the implant may have broken; and
· Dislocation – where the two parts of the implant that move against each other are no longer aligned.
The ASR Hip is made up of ball and socket components that move against each other. These metal components wear over time and generate very small particles that can only be seen with a microscope. This is an expected process. These particles do not cause problems for most patients, but a small number of patients may react to these particles, causing fluid to collect in the joint and in the muscles around the joint. While this condition may initially be painless, if left untreated, this reaction may cause pain and swelling around the joint and could damage some of the muscles, bones, and nerves around the hip.

 If you had hip surgery after July 2003:

DePuy does not maintain a list of patients who received an ASR Hip. Please
contact your orthopaedic surgeon or the hospital where your surgery took place
to determine whether you received an ASR Hip. It may take time for the surgeon
or hospital to locate this information for you.

For privacy reasons, your orthopedic surgeon or the hospital where your
surgery took place may ask you to request this information in person.
Once you have this information:

If you have an ASR Hip, please contact the DePuy ASR Help Line to
inform DePuy. This recall means additional testing and treatment may be
necessary to ensure your hip implant is functioning well. DePuy intends to
cover reasonable and customary costs of testing and treatment, including revision surgery if it is necessary, associated with the ASR recall.

To Contact DePuy:

You can call this Depuy number to answer any questions about this recall. 
 In the US and Canada:  1 888 627 2677 (9-5 EST Mon-Sat.)
Outside the US:  1 813 287 1651
Depuy Recall web site:  asrrecall.depuy.com
Summary of the Depuy claims  process can be found on this site:
 http://asrrecall.depuy.com/sites/default/files/Patient%20handout%20for%20claims%20and%20reimbursement%20process%20%28Sep%2024%2C%202010%20DPYUS%2033%29.pdf

No comments:

Post a Comment