October 27, 2010
As you may have read in our earlier reports, Johnson & Johnson subsidiary DePuy Orthopedics recently issued a major recall of two of its hip replacement systems. Since that time, we have been inundated with questions from hip replacement patients who are concerned and confused about what to do when a device implanted in their body is "recalled" by the manufacturer.
Due to the amount of confusion surrounding this issue, we've compiled a list of detailed answers for the most frequently asked questions. We hope this helps provide guidance for anyone affected by this hip replacement recall.
Q1. What types of hips are included in this hip implant recall?
are two types of hips that were recalled by DePuy: The ASR XL
Acetabular Hip System and the DePuy ASR Hip Resurfacing System.
Approximately 100,000 of these hips were distributed worldwide.
Q2. How do I know if I have and/or had a recalled hip?
The first thing you should do is call the surgeon who performed your
hip replacement surgery. All surgeons who used the recalled hips were
contacted by DePuy and advised of the recall. Therefore, the surgeons
should be aware of the recall and should be able to easily tell you
whether or not you have a recalled hip. If you are unable to get in
touch with your surgeon or he is non-responsive, we suggest you request
from the records department a copy of your "operative report" from the
date of your surgery. The operative report should identify the type of
hip that was used in your surgery.
Q3. Why were these hip implants recalled?
DePuy has indicated that it recalled the hips because it received data
from Europe indicating that people who received its hips required revision
surgeries at a rate that was more than five times what was expected.
Q4. What are some of the symptoms someone with a recalled or problematic hip might feel?
A4. Common symptoms include:
- Hip pain
- Loosening of the hip joint
- Swelling around the hip
- Hip or leg numbness
- Fracture of the implant
- Tumors at the site of the implant
- Flu-like symptoms
- Chronic fatigue
- Rashes and other skin conditions
Q5. Why does the "metal on metal" design of these implants cause problems?
much is still unknown about why people have been experiencing problems, many experts suspect that it is due to excessive wearing of
the implant and the subsequent release of metal debris into the joint. The hip consists of a metal ball (that connects to the
femur) and a metal cup (that is inserted into the hip socket). In an attempt to increase the longevity of these hips and their range of motion,
DePuy specifically designed the hips with a very shallow cup and large
ball. This design was substantially different than any other artificial
hip that had been manufactured before.
However, it appears that
DePuy's unique design for its artificial hip caused many unexpected
problems. Specifically, data suggest that many hips are experiencing
excessive wear along the edge of the cup and that this is causing large
amounts of metal debris to be released into the joint. Although the
released debris is very small, it can cause significant soft tissue
injuries as the body reacts to the metal. Specifically, the metal
debris can kill nerves and muscles in the joint and cause other problems
as the body's immune system tries to attack the foreign material.
are additional concerns that the release of metal debris into the joint
can cause problems throughout the body, known as metal toxicity. Many reports have shown
greatly increased cobalt levels (the primary metal that the hip is made
of) in the blood of individuals who have received these hips. Although
there is no definitive scientific proof at this point, there are
concerns that excessive cobalt in the blood system (cobalt toxicity) may cause heart
problems, dementia, loss of hearing or eyesight, and cancer. We are
advised that because of this recall, several studies are currently
underway to better understand the risks of excessive cobalt in the blood
Q6. If I'm not experiencing problems with my hip, do I still need a lawyer?
Yes. The extent of the long term problems
associated with these hips, including metal toxicity and cobalt toxicity, is currently unknown. For example, it is
presently unclear what types of long term disorders may be caused by
excessive cobalt in the blood. It is uncertain whether the cobalt
levels in individuals with these hips will increase over time. It is
also unclear what the failure rate of these hips will be as time goes
by. Present studies are showing a revision rate of 13% at 5 years.
However, many experts expect that revision rate to greatly increase as
the years go by. If excessive cobalt in the blood is definitively
linked to serious long term problems, doctors may eventually recommend
that all of the hips be removed.
Unfortunately, if you wait
until "something goes wrong" with your hip, you may be too late. The law requires people to file a lawsuit within a certain period of
time once they "suspect" there may be a problem with their hip. In some
states, this statute of limitations period can be as little as one
is no doubt that DePuy will argue that anyone who has been made aware of the
recall should "suspect" they have a claim, and thus the date of the
recall notice would mark the beginning of any applicable statute of
limitations. Therefore, it is a very real possibility that if some
catastrophic event occurs with your hip years down the road and you did
not initiate a lawsuit within your state's statute of limitations, you
will not be able to recover any damages for your injuries. To protect
yourself and your family, prompt action should be taken.
Q7. Should I sign documents allowing my medical records to be released to DePuy?
No. It is very important to understand that DePuy, as a company, is
attempting to minimize its liability and will attempt to use information
from your medical records to try and convince your doctor that any
problems you've been experiencing with your hip are not its
responsibility. This could potentially affect the way your doctor views
your condition and could impact your case down the road.
Q8. What types of tests should my doctor be performing?
A8. Since we are not doctors, it is difficult to recommend the treatment patients should be receiving. However, we can relay that most of the problems reported with these hips relate to soft tissue injuries; the destruction of muscle, nerves, etc, so X-Rays alone do not tell the whole story. Many additional tests, such as MRI's and blood tests are necessary to determine the extent of the damage.
DePuy has put out a decision tree that it has asked surgeons to follow in treating patients with recalled hips. Click here to see the tree.
To better understand if your doctor is "doing the right thing," we recommend that you bring the decision tree into your doctor and ask questions about each of the steps outlined in the tree. Communication with your doctor is the most important thing you can do in dealing with the situation.
Q9. If my doctor wants to replace my hip, what should I do?
A9. IT IS VERY IMPORTANT TO SPEAK WITH AN ATTORNEY IF YOUR DOCTOR WANTS TO REPLACE YOUR HIP. One of the most important pieces of evidence in your case may be the artificial hip once it is removed from your body.
There are many tests that can be performed on the removed hip to determine if there has been excessive wear as described above. Therefore, steps must be taken to ensure that your surgeon maintains the removed hip and, most importantly, does not send it off to DePuy for analysis. At Kershaw, Cutter & Ratinoff, we have developed a protocol to ensure that your surgeon does not discard your hip and that he maintains it in a way that will ensure its admissibility in a legal procedure.
If you or someone you know has received a notification regarding the DePuy hip replacement recall, please contact our hip replacement recall legal team at 888-285-3333 for a free and confidential case evaluation.
For more information on cobalt &
chromium toxicity, visit our new website that features in-depth
interviews with renown metal toxicology expert: www.cobalt-chromium-toxicity.com