A lawsuit has been filed against hip replacement manufacturer DePuy Orthopaedics, Inc over failure of a DePuy ASR metal-on-metal hip replacement. The lawsuit against DePuy was filed in Federal District Court in Ft. Myers, Florida . This is believed to be the first lawsuit filed in the United States over the failure of the DePuy ASR hip replacement. The patient in the suit is represented by an alliance of law firms pursuing claims on behalf of patients across the nation with failed DePuy ASR hip replacements.
The lawsuit alleges that the DePuy ASR hip replacement was defectively designed. It claims DePuy knew that their ASR hip replacements were failing at a higher than expected rate, yet it did not pass that information on to consumers or orthopaedic surgeons. As a result, diagnosis that the ASR hip replacement implanted in the patient has failed was needlessly delayed as her physicians were unaware of the prevelance of other failures. During the patient’s surgery to replace the failed hip replacement, her orthopedic surgeon discovered that the cup portion of the ASR hip replacement was extremely loose. The ASR hip replacement is designed so that a patient’s bone grows into the back of the cup to secure it. However, loosening because of a lack of bone in-growth into the cup is a hallmark of DePuy ASR hip replacement failures.
Unfortunately, DePuy’s recall of the ASR systems comes too late for patients that were sold these devices. This is not a typical recall where the toy with lead paint can simply be discarded or returned to the manufacturer for a refund. This recall is for a product that has been implanted in a person’s hip. As a result, the recalled product can only be replaced with the patient going through a painful and debilitating surgery and rehabilitation.
Many observers expect this already high failure rate to increase dramatically as problems with the DePuy ASR hip systems become more widely publicized. Denying that its decision to do so was related to reports of failures of the ASR systems, late last year DePuy ceased sales of the products. Unfortunately, by that time, almost 100,000 of the systems had been implanted in patients worldwide. DePuy Orthopaedics, Inc. is the orthopedic subsidiary of Johnson & Johnson.
According to DePuy, reported problems with the DePuy ASR hip systems include the following:
* Loosening, when the implant does not stay attached to the bone in the right 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.
In March of this year, the New York Times published an article about the high early failure rate of DePuy’s ASR hip replacement. Since that article was published many more reports of failures of ASR hip replacements have been received by both DePuy and the United States Food and Drug Administration. In its article, the New York Times quoted orthopedic experts critical of the design of the ASR hip replacement. Experts were also critical of DePuy’s failure to stop sales of the device sooner.
If you have a DePuy ASR hip replacement or hip resurfacing, and are experiencing problems with the device, you need to consult with an experienced medical product liability attorney immediately. It is best to retain an attorney before undergoing a revision surgery so that potentially important evidence can be preserved. Furthermore, by law there is a limited period of time in which you may bring a legal action against DePuy for a failed ASR hip system, so don’t delay.
Zimmer – Durom Cup
Zimmer, Inc. recalled their prosthetic hip implant in July 24th, 2008. Their Durom Cup hip replacement has been implanted in 12,000+ patients when it was introduced in the US in 2006.
If you are uncertain if you have either of the recalled Hip Systems, contact your orthopedic surgeon. Your primary care physician or the hospital where the surgery took place should be able to provide you with the name of your surgeon if you can’t recall who performed the original surgery.
Symptoms of a Durom Cup hip failure include:
• Unexplained Hip Pain
• Thigh Pain or Groin Pain
• Pain with Walking
• Pain Rising from a Seated Position
• Pain with Weight Bearing
* Depuy ASR XL Acetabular System
* Depuy ASR Hip Resurfacing System
Other Hip Implants that have been recalled:
* Zimmer Durom Cup
* Stryker Trident PSL
* Stryker Trident Hemispherical Acetubular Cup
Speculation Mounts About Potential Recall of DePuy Pinnacle Metal-on-Metal Hip Replacements
April 10, 2011
In the months since a recall of the DePuy ASR XL artificial hip, DePuy might be facing the recall of yet another one of its hip replacements, the Pinnacle Acetabular Component, which has been facing increased scrutiny for its premature failures.
Like the ASR XL, the Depuy Pinnacle is a metal on metal system that was designed to last at least 10-15 years but now, orthopedic surgeons are reporting that these devices have been failing within one to two years of being implanted into their patients.
That’s not good news for DePuy, a division of Johnson & Johnson, which has implanted over 150,000 Pinnacle hip replacements into patients since it was put into service in 2001. Its recent recall of the defective ASR metal-on-metal hip implant systems has forced thousands of hip implant patients to have additional, painful and expensive hip revision surgeries.
Although the ASR and Pinnacle are both metal on metal systems, there are significant differences between the two insofar as:
* the ASR is a monoblock design whereas the Pinnacle uses a modular system.
* the ASR cup is made of one solid piece of metal whereas the Pinnacle has an outer shell
* The Pinnacle is designed in such a way that the surgeon has the option to place a metal, ceramic or polyethylene liner inside the metal outer cup
Much of the problem seems to be with the Pinnacle 36 mm Ultamet Metal-on-Metal component which is failing at an unacceptably high rate. One of the theories seeking to determine the cause suggests that a design problem flows from the fact that the device has been created with one of the lowest clearance levels in the industry. The only other implant with a clearance level this low is the DePuy ASR.
Attorneys and experts investigating the basis for the high rate of failure point to the product design and believe that DePuy created a very narrow window for proper placement of the prosthesis and inadequately trained surgeons in the proper implantation technique.
Like, the recalled DePuy ASR system, the Pinnacle was permitted to reach the market under the U.S. Food and Drug Administration’s (FDA) controversial 510(k) approval process, which allows a medical device to be placed on the market without being subjected to necessary clinical trials as long as the manufacturer can show that the device is “substantially equivalent” to a device already approved on the market. DePuy’s ASR system avoided obligatory clinical trials by showing that it was fundamentally similar to the DePuy Pinnacle hip replacement system, raising some serious issues.
Recently, the FDA has received hundreds of complaints and adverse incident reports against the Pinnacle system, attributed mostly to the Pinnacle’s propensity to prematurely separate from the bone. Moreover, like many other metal on metal devices, constant friction in the Pinnacle may cause an increased risk of metallosis, i.e. the release of miniscule metal particles into the surrounding soft tissue or bloodstream.
All of this has resulted in a wave of new lawsuits being filed around the country against DePuy. Just last week, a motion was filed in the United States District Court in California seeking to consolidate all DePuy Pinnacle cases before one judge in what is known as a multi district litigation, or MDL. The MDL Panel is scheduled to rule on this application in May.
In the interim, our hip replacement team continue to investigate claims of Pinnacle failures and counsel our clients on what to do in the event that they need revision surgery.
If you or a loved one have been implanted with a DePuy Pinnacle hip replacement and are experiencing any pain or disability:
-See a doctor immediately.
-Do not release any of your confidential medical information to any DePuy representatives before speaking to experienced hip replacement counsel.
-If you are told that you will need hip revision surgery, make sure that the removed component parts are preserved. Your counsel should be familiar with this process and be working with the proper experts to insure that it is done correctly.
For further information and to consult with our hip replacement litigation helpline call 1.877.522.2123.
If you or a loved one has experienced any of the following Symptoms you may have a recalled hip implant!
* Serious Constant Pain
* Clicking or Popping
* Hip Fracture
* Loosening of the Implant
* Implant Dislocation
Attorneys for the depuy hip replacement lawsuits In:
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