DePuy Pinnacle Hip Metal Liner Discontinued Amid Lawsuits, Problems
Amid a growing number of DePuy Pinnacle hip lawsuits and mounting concerns about problems with metal-on-metal hip replacement systems, DePuy has announced that it is discontinuing the metal line made exclusively for the Pinnacle Acetabular Cup system.
In a press release issued today, DePuy Orthopaedics, Inc. indicated that it is stopping sales of the Ultamet metal-on-metal and Complete ceramic-on-metal hip systems, which include the same metal liner that is designed exclusively for use with the DePuy Pinnacle hip in a metal-on-metal configuration.
In addition to citing low sales for the metal liner, the company noted that proposed FDA regulation of metal-on-metal hip implants was a factor in discontinuing sales.
The FDA has called for metal hip manufacturers to go through more stringent clinical trials and premarket approval processes before placing artificial hip products on the market. Part of the reason the agency was pushed to its decision was due to an August 2010 recall of the DePuy ASR metal-on-metal hip implant that affected more than 93,000 artificial hip systems worldwide and led to thousands of lawsuits against the company.
The DePuy Pinnacle hip system was introduced in 2001, with some variations containing the metal liner. The metal-on-metal configuration was used as the basis for the approval of the DePuy ASR hip implant in 2005, with Johnson & Johnson obtaining “fast track” 510k approval by maintaining that the DePuy ASR and DePuy Pinnacle metal-on-metal hips feature “substantially similar” designs. However, the DePuy Pinnacle was also approved under the FDA’s controversial 510k system as a substantial equivalent to older metal hips, which has allowed both designs to be implanted in thousands of people without federal regulators requiring stringent clinical trials to examine the safety of the design.
The company’s press release says that the Pinnacle Cup is not affected by the discontinuation, indicating that the Pinnacle will continue to be offered with both medical-grade plastic and ceramic liners.
DePuy Pinnacle Hip Lawsuits and Calls for Recall
More than 4,000 product liability lawsuits have been filed throughout the federal court system by people who have experienced problems with the DePuy Pinnacle hip when it was implanted with the metal liner. The lawsuits allege that as the metal parts rub against each other, metallic debris is released into the body, which may cause the artificial hip to loosen and ultimately fail.
Many of these complaints allege that a DePuy Pinnacle hip recall should have been issued after post-marketing reports made it clear that an unreasonable number of patient were experiencing complications within a few years of surgery.
Although Johnson & Johnson’s DePuy subsidiary has kept the Pinnacle metal liner on the market, most doctors have abandoned use of all metal-on-metal configurations due to concerns about the safety.
DePuy acknowledges the sharp decline in the use of metal-on-metal hip replacement systems worldwide that is driving it to consolidate its products. The company says that metal-on-metal systems now make up less than 2% of those implanted annually in the U.S. and Europe; a 90% decline industry-wide since 2007.
All Metal-on-Metal Hips Under Investigation
In recent years, the FDA has increased scrutiny of metal-on-metal hips in response to concerns about the effects of metallic debris that may be released as the metal parts rub against each other, potentially causing tissue damage and metal blood poisoning, also known as metallosis.
In January, the FDA released new guidance for metal-on-metal hip replacements that called for them to go through the PMA process. The agency told doctors that metal-on-metal hip replacement systems should only be used if other artificial hip implants were not appropriate, and called on manufacturers to prove that their implants were safe enough to stay on the market.
Thousands of individuals throughout the United States are currently pursuing product liability lawsuits against the makers of metal-on-metal hip replacement systems. In addition to lawsuits over the DePuy Pinnacle, a substantial number of DePuy ASR hip lawsuits, Biomet M2A Magnum Hip lawsuits and Wright Conserve Cup lawsuits are pending nationwide.
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