Speculation Mounts About Potential Recall of DePuy Pinnacle Metal-on-Metal Hip Replacements

 

 

Manhattan lawfirm of Bohrer & Lukeman is investigating claims and preparing to file lawsuits on behalf of Pinnacle recipients.

 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, Bohrer & Lukeman and its 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 an experienced hip replacement attorney at no cost or obligation, call the attorneys at Bohrer & Lukeman at (212)406-4232.