On August 2010, there was a recall of the DePuy ASR XL artificial hip, and now DePuy may be facing the recall of the Pinnacle Acetabular Component. All federal lawsuits over DePuy Pinnacle hip replacement problems have been consolidated for pretrial proceedings as part of an MDL, or multidistrict litigation, which will be centralized in the U.S. District Court for the Northern District of Texas, Dallas.
The U.S. Judicial Panel on Multidistrict Litigation issued an order establishing the MDL, which will result in the transfer of 60 DePuy Pinnacle hip lawsuits currently pending in federal district courts throughout the United States.
Like the DePuy 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.
DePuy, a division of Johnson & Johnson, has implanted over 150,000 Pinnacle hip replacements since 2001. Its recent recall of the defective ASR metal-on-metal hip implant systems has thousands of hip implant patients to have additional hip revision surgeries.
The ASR and Pinnacle are both metal on metal systems, and the ASR is a monoblock design, the Pinnacle uses a modular system. The ASR cup is made of one solid piece of metal, the Pinnacle has an outer shell and the Pinnacle is designed allow the surgeon the option to place a metal, ceramic or polyethylene liner inside the metal outer cup.
The Pinnacle 36 mm Ultamet Metal-on-Metal component is failing at an unacceptably high rate. Research suggests that there is a design problem, and the device has been created with one of the lowest clearance levels in the industry. Experts investigating the product design believe that DePuy created a very narrow window for proper placement of the prosthesis and inadequately trained surgeons in the proper implantation technique.
The recalled DePuy ASR system and the Pinnacle was permitted under the U.S. Food and Drug Administration’s (FDA) 510(k) approval process, which allows a medical device to be placed on the market without being subjected to 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 clinical trials by showing that it was similar to the DePuy Pinnacle hip replacement system.
The FDA has received complaints and adverse incident reports against the Pinnacle system, and the Pinnacle’s propensity to prematurely separate from the bone. Constant friction in the metal on metal Pinnacle causes an increased risk of metallosis, the release of metal particles into the surrounding soft tissue or bloodstream, particularly chromium and cobalt.
The Dr Shezad Malik Law Firm hip replacement team continues to investigate claims of Pinnacle failures and counsel our clients on what to do in the event that they need revision surgery.
