Hip implants

About Metal-on-Metal
Contact Michael H. Monheit,
Esquire
Hip Implants
Email:
mmonheit@anapolschwartz.com
CONTENTS
Toll Free: (866) 735-2792 Bad News: DePuy Hip Implant Recalls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3
FDA Medical Device Report For The Wright Conserve Hip . . . . . . . . . . . . . . . . . . . . . . 3
Read more information online at: High Risk Broken Hip Implant Injury . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
www.anapolschwartz.com Wright Metal on Metal Hip Implants . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4
Marketing, Clinical Trials for Wright Hip Resurfacing System . . . . . . . . . . . . . . . . . . . . 5
© 2012 All Rights Reserved. What is the performance of the CONSERVE Plus Total Hip Resurfacing system
under actual use conditions? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
MEDICAL DISCLAIMER: This PDF DePuy Hip Replacements—Sometimes the Problem Can’t be Fixed . . . . . . . . . . . . . . 6
is not designed to and does not provide What a Hip Recall Really Means . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
medical advice, professional diagnosis, Senate Committee Holds Medical Device Safety Hearing . . . . . . . . . . . . . . . . . . . . . . . 7
opinion, treatment or services or other-
FDA Requests More Info from DePuy and Others About Hip Replacements . . . . . . . . . 7
wise engage in the practice of medicine,
to you or to any other individual. Please What You Should Know About Conserve Hip Implants . . . . . . . . . . . . . . . . . . . . . . . . 7
use this information to help in your Could New Requirements be Ahead for Medical Device Manufacturers?. . . . . . . . . . . 8
conversation with your physician. This is When a Recovery From Hip Implant Surgery Is Not Normal . . . . . . . . . . . . . . . . . . . . . 8
general information and always seek the
Why Did the ASR Hip Fail Me? . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
advice of your physician or other quali-
fied health provider with any questions
you may have regarding a medical condi-
tion. Never disregard or delay seeking ATTORNEY DISCLAIMER: This PDF is dedicated to providing general public information regarding legal
professional medical advice or treatment rights. None of the information on this PDF is intended to be formal legal advice, nor the formation of a lawyer
because of content found in the PDF, or attorney client relationship. Please contact a Lawyer for information regarding your particular case. This PDF is
website, or newsletter. not intended to solicit clients outside the states of Pennsylvania, New Jersey, Ohio, West Virginia and Arizona.

Metal-on-Metal hip implants (also known While orthopedic surgeons take precautions to try and control how the
as MoM) consist of a ball, stem and shell, all ball and socket rub against each other, there is no way to totally avoid
the metal particle production. People react differently to these metal
made of metal materials. MoM hip implant
particles.
systems may be more suitable for younger
and physically active patients because the Over time, metal particles around some implants can cause damage
to bone and/or tissue surrounding the implant and joint. This is some-
metal is durable enough to last a long time.
times referred to as adverse local tissue reaction or adverse reaction to
metal debris. Either of these adverse reactions may cause the MoM hip
MoM hip implants were designed implant to become loose or cause pain requiring replacement surgery
to offer these benefits: where the old device is removed and replaced with another one.

• Decreased chance of device fracture Patients who have MoM hip implants should be educated by their
healthcare team about potential symptoms which might occur after
• Decreased chance of dislocation when the
surgery which indicate their MoM hip device is not functioning cor-
ball of the thighbone or femur slips out of its
rectly. Such symptoms include:
socket in the hip bone or pelvis
• Less total material being removed from the • Pain in the groin, hip or leg
ball and socket when rubbing against each • Swelling at or near the hip joint
other as compared to other hip implant
• A limp or change in walking ability
systems
Some metal on metal hip implant systems like DePuy ASR™ XL Ac-
What are the two types of etabular System and Zimmer Durom® Acetabular Component have
voluntarily been recalled. This doesn’t mean that every hip implant is
MoM hip systems?
bad. Or conversely, if a MoM hip device has not been recalled, that
• Traditional total hip replacement implant doesn’t mean it is free of adverse side effects.
• Total resurfacing hip implant Patients who have received a metal on metal hip implant should pay
close attention to changes in their general well being and let your
Because the metal ball and the metal cup slide
healthcare professional know if you suffer from any of these ailments:
against each other during walking or running, some
tiny metal particles may wear off the medical device • Heart—chest pain, shortness of breath
and enter into the space around the implant.
• Nerves—numbness, weakness, change in vision or hearing
• Thyroid—fatigue, feeling cold, weight gain
Some of the metal ions from • Kidney—change in urination habits
the metal implant or from
the metal particles may even
get into your bloodstream.

ABOUT METAL-ON-METAL HIP IMPLANTS
Copyright © 2004–2012 All rights reserved. Anapol Schwartz.
Read more information online at www.anapolschwartz.com.
2

BAD NEWS: DEPUY HIP While many patients will have no problems, they may be haunted by
the DePuy hip implant recall. These are the luckier ones.
IMPLANT RECALLS
Other patients with pain, swelling, and trouble walking will need to
DePuy Orthopaedics, a division of Johnson &
have additional surgeries to remove the defective hip implant and will
Johnson is recalling its ASR™ XL Acetabular Sys-
need to find another solution to hip repair.
tem (available in the United States) and DePuy
ASR™ Hip Resurfacing System. Both are hip im- DePuy claims it will pay for reasonable costs but at what cost? How
plants. can you put a price tag on pain and suffering?

Every day there are recalls for food, home prod-
ucts, cars, diet supplements, and pharmaceutical FDA MEDICAL DEVICE REPORT FOR
drugs. But what could be worse than a medical THE WRIGHT CONSERVE HIP
device recall that is already implanted in your
body during an invasive surgery requiring painful From August 1997 to November 2011 the FDA received more then 862
recovery and a long inopportune rehabilitation? individual reports from people who had used the Wright Conserve Hip.
Women of small stature and people with weak
Reported events:
bones face the highest risk.

This hip implant recall means additional testing
and monitoring may be necessary to ensure your
hip implant is functioning well. In some cases pa-
tients may need additional surgery known as revi-
sion surgery.
Event Totals:
After more than two years of reports about early
hip implant failure, DePuy Orthopaedics issued a Injury . . . . . . . . . . . 835
warning letter to doctors about the medical de-
Malfunction . . . . . . 25
vice asking for assistance in notifying patients
about the recall and answering questions that Other . . . . . . . . . . . 2
patients might have. The warning comes months
after the company announced plans to phase out
Complications of Wright Conserve Hip
the product because of slowing sales.
Some of the complications experienced after using the Wright Con-
What does this mean for hip serve Hip include:
implant patients? Grief.

At best it means that patients with DePuy hip
implants will have to be tested and monitored.

3

Wright Conserve Hip Injuries HIGH RISK BROKEN HIP IMPLANT INJURY
Associated with Many Brands
According to a recent study funded by the U.S. National Institutes of
Injuries have been associated with many manufac- Health, older women who break a hip are more likely to die within a
turers and brands including Conserve® Total A-class year because of their broken hip. It’s unsettling because the broken hip
Head, Conserve® Plus Cup, Conserve® Total Head is the cause of death, not another health condition.
W/bfh, Conserve® Plus Ha Cup, Conserve® Total A-
And what’s more unsettling is that women are at the highest risk of
class, Conserve® Super Finish Femoral, M2a Modular
dying within the first three months after a hip fracture. Hospitalization,
Head Component 38mm Head Diameter, Conserve®
surgery, and immobility lead to complications resulting in death.
Plus Spiked Cup, M2a Modular Head and M2a 38mm
Modular Head. As part of a larger ongoing study involving nearly 10,000 women
aged 65+, researchers followed 1,116 women who broke a hip and
compared them to nearly 4,500 similar women who didn’t break a
hip.

The study, published in the Archives of Internal Medicine, found that
women between the ages of 65 and 69 who break a hip are five times
more likely to die within a year than their peers who didn’t suffer a
fracture.

What is also unsettling is that more adverse side effects are show-
ing up in the FDA database for Wright Medical Conserve hip implant
cup. A medical device, the hip implant is inserted into the hip ball and
socket. Metal on metal implants are supposed to last 15 to 20 years
but replacement surgery is now being needed within 3 to 5 years.

WRIGHT METAL ON METAL HIP IMPLANTS
Metal-on-metal bearings for hip surgery have been in clinical use for
more than 20 years, mostly with good results. A small percentage or
less than 1 percent of patients may develop inflammation. Lately, a
more severe inflammatory response called pseudotumor has been re-
ported.

A Canadian study was recently conducted to determine the prevalence
of pseudotumor following metal-on-metal hip resurfacing in Canadian
academic centers.

4

The advantages of metal-on-metal hip systems MARKETING, CLINICAL TRIALS FOR
are to provide hip implant patients with durability,
range of motion and joint stability for younger, more
WRIGHT HIP RESURFACING SYSTEM
active patients. These metal to metal implants are Here are parts of the FDA’s premarket approval letter dated Novem-
made of a cobalt-chrome alloy. The ball and socket ber 2009 for the Conserve Plus Total Resurfacing Hip System made by
can be manufactured to closely match the size of Wright Medical Technology, Inc.
the patient’s own joint, allowing for more natural
functioning. The CONSERVE® Plus Total Resurfacing Hip System is a single use de-
vice intended for hybrid fixation utilizing cemented femoral head com-
However, disadvantages and risks include metallic ponent and cement-less acetabular component.
debris that might lodge in tissues surrounding the
joint, metallic ions that travel through the body in The CONSERVE® Plus Total Resurfacing Hip System is intended for use
the bloodstream, and possible dislocation of the in resurfacing hip arthroplasty for reduction or relief of pain and/or
joint. Replacement also known as revision surgery is improved hip function in skeletally mature patients having the follow-
necessary if there is a problem. ing conditions:
• Non-inflammatory arthritis (degenerative joint disease) such
But back to Canada, nine of the 14 centers that as osteoarthritis, traumatic arthritis, avascular necrosis, or
perform metal-on-metal hip resurfacings were sur- dysplasia/developmental dislocation of the hip, or
veyed. At the nine centers, 3,432 hip resurfacing
• Inflammatory arthritis such as rheumatoid arthritis.
surgeries were performed; 76.9% of the patients
were male, the mean age was 51.2 years (range, 16 The CONSERVE® Plus Total Resurfacing Hip System is intended for pa-
to 83 years), and the mean body-mass index was tients who, due to their relatively younger age or increased activity
28.1 (range, 17 to 55). The mean length of follow- level, may not be suitable for traditional total hip arthroplasty due to
up was 3.4 years (range, two to 9 years). A pseu- an increased possibility of requiring future hip joint revision.
dotumor developed after four of the 3,432 surgery,
for a prevalence of 0.10%. The letter goes on to say that approval is granted but conditions follow
such as agreeing to two post approval studies:
In conclusion, although pseudotumors remain a con-
cern after metal-on-metal hip resurfacing, the preva- Long-term use: This study is designed to evaluate the longer term
lence at short to midterm follow-up is very low in safety and effectiveness of the CONSERVE Plus Total Resurfacing Hip
this multicenter survey. Continued close monitoring System. Specific study questions to be answered are:
is required to determine what clinical factors are in- 1. What is the longer-term safety performance of the CONSERVE
volved with the uncommon pseudotumor formation. Plus Total Resurfacing Hip System?
2. What is the longer-term effectiveness performance of the
However, if you are in the percentage of patients
CONSERVE Plus Total Resurfacing Hip System?
who do suffer from pseudotumors caused by Wright
metal on metal hip cup implants—the problem is New enrollment study: This study is designed to examine the perfor-
real and may require legal intervention. mance of the CONSERVE Plus Total Resurfacing Hip System in newly
enrolled patients under real world conditions of use.

5

WHAT IS THE PERFORMANCE OF er people have suffered other medical problems, such as heart attacks,
that make them reluctant or unable to have surgery because of the
THE CONSERVE PLUS TOTAL HIP risks presented by the anesthesia.
RESURFACING SYSTEM UNDER
If you received a DePuy A.S.R. hip replacement then it is important to
ACTUAL USE CONDITIONS? talk to your doctor as soon as possible about your risks and about what
Currently, the clinical trial is seeking patients who your next steps should be to ensure your safety.
have already undergone hip resurfacing in the CON-
SERVE Plus IDE. The estimated completion date is WHAT A HIP RECALL REALLY MEANS
November 2015.
You know that feeling of aggravation you have when you open the
Patients who already suffer from serious Conserve mail to find a letter recalling your car or appliance? Nobody wants to
Hip Resurfacing side effects don’t need a clinical deal with the hassle of returning the item to get a new item or getting
trial; they need legal intervention. an existing item fixed. Even if the company insists that the recall is
“free” it still costs you time and energy that could be spent elsewhere.
DEPUY HIP REPLACEMENTS— Now imagine that the recall isn’t for one of your goods but instead for
SOMETIMES THE PROBLEM a medical implant that is already in your body. The “free” recall now re-
CAN’T BE FIXED quires you to undergo another surgery and the risks associated with that
surgery. It also requires you to take time away from work, your family, or
An interesting article about the DePuy A.S.R. hip re- the activities that you enjoy. In other words, it is anything but free.
placement issue appeared in last week’s New York
Times. The article, The Implants Loophole, discussed A recall such as The DePuy Hip Replacement Recall does not fix the
many important issues including what the FDA and problem. It doesn’t make up for the harm done. Yet, it is important that
Johnson and Johnson could have done differently to you talk to a doctor about the recall and about how best to protect
prevent the problem. your health in light of the recall so that any medical problems can be
minimized.
However, perhaps the most important part of
the article is the individual stories it shares about
people who have been affected by a defective
A.S.R. While DePuy would have you believe that
you can simply have another operation to fix the
defective device—and that DePuy will pay your
expenses—it is not always that easy.

Some people have such extensive damage to the
bone, tissue and nerves in the area of the replace-
ment that they are permanently disabled—even
after a subsequent hip replacement surgery. Oth-

6

SENATE COMMITTEE FDA REQUESTS MORE INFORMATION
HOLDS MEDICAL DEVICE FROM DEPUY AND OTHERS
SAFETY HEARING ABOUT HIP REPLACEMENTS
Last week, the U.S. Senate Special Committee on On May 6, 2011 the FDA asked Johnson & Johnson to provide more
Aging held a hearing to look at the FDA’s approval of data about the level of metal found in patients’ blood after hip re-
medical devices and the agency’s role in protecting placement operations. Specifically, the FDA is requesting that Johnson
patient safety as it relates to medical devices. & Johnson, DePuy Orthopedics, Zimmer Holdings and others study the
levels of cobalt and chromium for at least 8 years after implant of all
The hearing included testimony about the Govern-
metal devices, some of which have already been recalled.
ment Accountability Offfice’s (GAO) Investigation into
the FDA’s management of medical device review. Ac- The FDA is requesting this information because of a possible link be-
cording to the GAO, concerns remain about the FDA’s tween the metal levels detected in the blood and pain, tissue damage
ability to assure the public that devices are safe, to and the need for additional surgeries. We will continue to monitor any
monitor devices after they are in the marketplace, and further reports that come from the FDA or hip replacement manufac-
to ensure that medical device recalls are effective. turers regarding the results of this data.

Also testifying was the lead author of a recent study
which found that medical device recalls continue to WHAT YOU SHOULD KNOW ABOUT
be a problem in the United States. The study, led by CONSERVE HIP IMPLANTS
Dr. Diana Zuckerman, was published in The Archives
of Internal Medicine. The study found that in the first In 2009, the Conserve ® Plus Total Resurfacing Hip System was ap-
half of 2010 more than 437 million medical devices proved by the FDA. The device is manufactured by Wright Medical
were recalled by the FDA. That means that in just six Technology, Inc. and is approved to treat fractures, osteoarthritis,
months, approximately 1.4 devices were recalled for rheumatoid arthritis and avascular necrosis in hip joints. Since its ap-
every person living in the United States. proval, more than 200 adverse event reports have been received by
the FDA and lawsuits have been filed alleging that the device failed
During the testimony, the Senate Committee heard prematurely resulting in harm.
the story of a woman who had to undergo a second
hip replacement surgery after her DePuy hip replace- The Conserve device is a metal on metal hip replacement system. Some
ment was recalled. of the harm that has been allegedly been caused by these devices in-
clude:
The Chairman of the Senate Special Committee on
• Metallosis;
Aging has indicated that he is interested in the FDA
developing a “more robust post-market surveillance • Biologic toxicity; and
program” before the Medical Device User Fee and • Early failure rate of the device.
Modernization Act comes up for reauthorization in
Many of these problems have allegedly been caused by the release of
2012.
metal particulars from the devices into the patients’ bodies.

7

COULD NEW REQUIREMENTS plant failed and that you need immediate medical attention. For exam-
ple, the premature failure of metal on metal hip replacement systems,
BE AHEAD FOR MEDICAL such as the Wright Medical Technology Inc’s Conserve Hip Implant Sys-
DEVICE MANUFACTURERS? tem, can result in metal being released into the blood and surrounding
tissue. This can cause significant complications.
A new bill was introduced in the United States Sen-
ate that would change the way medical implants are If you experience any pain or other unusual symptoms after a Con-
monitored. The bill would require medical device serve Hip Implant replacement surgery then please see your doctor
manufacturers to track the performance of implants right away for a full examination and treatment plan.
after they have FDA approval.

The legislation would impact medical implants that WHAT WILL DEFECTIVE
are currently approved by the FDA without human ARTIFICIAL HIPS COST US?
testing through a process known as the 510(k) pro-
cess. Approval via 501(k) requires the manufacturer The problems associated with metal on metal artificial hips are thought
to prove that its device is substantially similar to one to be among the most significant defective medical device issues of the
already on the market without any human testing. past few decades. As more and more patients come forward with pain-
ful and dangerous complications associated with artificial hips from
The Senators who sponsored the bill believe that the different manufacturers, the cost of the defective products continues
legislation, if passed into law, would allow the FDA to soar.
to gather necessary data and protect patients with-
out slowing down the initial approval process.
Billions in Damages are Expected
WHEN A RECOVERY FROM Last week, the New York Times* estimated the cost of these defective
hip replacements to be billions of dollars in the coming years. These
HIP IMPLANT SURGERY costs will likely be borne by individuals, employers, insurers and tax-
IS NOT NORMAL payers. (*The High Cost of Artificial Hips by Barry Meier, New York Times, December 27, 2011.)
Generally, patients undergo hip replacement surgery
with the hope that their quality of life will improve. SHOULD YOU REQUEST THE
They hope to be in less pain than they were in prior
NEWEST HIP REPLACEMENTS?
to surgery.
Maybe not. Newer may not always be better when it comes to medical
While pain is normal in the immediate aftermath
devices according to a recent study published in a November 2011 edi-
of surgery and during the 4–6 week recovery from
tion of BMJ. The study found that none of the new hip replacements
surgery, your quality of life should improve after the
introduced in the last five years led to better results than hip replace-
recovery period.
ments that were already on the market and some performed worse.
If pain returns or you experience symptoms of infec- The newer hip replacements included the metal on metal hip replace-
tion then it is possible that your hip replacement im- ments that are allegedly defective and the subject of many lawsuits.

8

As a patient, this information means that you should CONTACT US
talk about your options with your surgeon and agree
on a hip replacement device with which you are both Have you suffered from an artificial hip? Have you been out of work
comfortable prior to surgery. Additionally, it means and in pain? Have you required additional surgeries or suffered perma-
you should ask about potential complications and nent complications? If you have then you may be entitled to damages
discuss proper follow up care so that any complica- for your injuries.
tions can be dealt with promptly. If you or your loved one has endured a MoM hip implant and suf-
fered serious side effects or needed a replacement hip—please con-
WHY DID THE ASR HIP FAIL ME? tact Anapol Schwartz, a leader in unsafe medical device cases like the
MoM hip implant. Talk to a lawyer to find out the facts about your
Since 2008, hundreds of people have asked this very legal options. A medical device lawyer represents the interests of those
question. Why did the ASR hip fail? This type of hip who have been harmed by or lost loved ones as a direct result of a
replacement failed because its metal on metal de- dangerous medical device. A medical device attorney may represent
sign may allow metal to be released into the body an individual client or take part in a mass tort action. Call us toll free
and may cause premature failure of the replacement at (866) 735-2792 to schedule a private, no-cost consultation with an
hip joint. In other words, the Depuy ASR implant ma- attorney who can evaluate your claim and get your case started.
terials, or more specifically the metal parts, are likely
what is causing ASR hip failures.

When Did Depuy ASR Start to Fail?
It has been at least four years since the first claims of
Depuy ASR failures have been reported to the FDA.
If you have received an ASR hip implant then it is im-
portant to talk to your doctor about possible symp-
toms of failure and to know what to do when those
symptoms present themselves.

9

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