The DePuy Pinnacle Acetabular Cup Liner is a metal liner designed for use with the Pinnacle Acetabular Shells and the matching femoral head. The implant system was constructed with a proprietary alloy containing cobalt, chromium, and molybdenum, and was created to increase mobility and last longer than other hip implant devices.
The DePuy Pinnacle Hip Implant was approved by the U.S. Food and Drug Administration (FDA) in 2000 through the 510(k) process, which allows medical devices that are considered to be “substantially similar” to products already approved by the FDA to go through a more expedited approval process.
After entering the market, the Pinnacle Hip Implant was promoted by DePuy as a convenient option for younger hip replacement patients. DePuy claimed that the device could last for up to 20 years and solved a common hip replacement problem—breakdown from overuse. Since 2000, over 150,000 Pinnacle Hip Implant devices have been sold.
Less than four years after the FDA approved the Pinnacle Hip Implants, many patients began to complain that the device’s metal-on-metal design was breaking down much quicker than manufacturers had promoted. The premature breakdown of the product created metal debris, which became absorbed by surrounding tissue, causing multiple health problems for patients, including an increased failure rate, metallosis, infection, dislocation and immobility. More long-term adverse side effects included cobalt poisoning, which can lead to cognitive and cardiac damage. Some studies even mentioned an increased cancer risk. This has ultimately resulted for patients to need for a revision surgery.
While DePuy has recalled several other hip replacement products, including the ASR Hip Resurfacing System and the DePuy ASR XL Acetabular System, the company chose not to recall on the Pinnacle Hip Implant system. Instead, Depuy discontinued the product in August 2013 after the FDA informed the company that it would be required to submit new versions of the product for pre-market approval.
Also in 2013, the FDA issued a safety communication regarding metal-on-metal hip implants. The FDA warned patients that friction from walking and performing everyday activities might cause the metal ball and the metal cup to release particles of metal, causing an “adverse reaction to metal debris,” such as bone and/or soft tissue damage. The safety communication also cautioned patients that metal-on-metal hip implants may lead to elevated levels of metal ions, like cobalt or chromium, in the bloodstream and urged patients to seek out metal ion testing.
In addition to issuing warnings about the safety of metal-on-metal hip implants in general, the FDA reported receiving more than 1,300 adverse event reports for the Pinnacle Hip Implant system. The reports mentioned severe pain in the area surrounding the implant, difficulty moving, as well as reports of synovial inflammation and metallosis. A DePuy representative told the FDA advisory panel that the rate of revision surgery over a period of five years for Pinnacle Hip Implants was consistent with other products on the market at 4% to 4.5%. However, reports on the rate of revision surgery for the Pinnacle Hip Implant system varied from source to source.
The British Hip Society reported that the metal-on-metal design utilized in the Pinnacle Hip Implant system had a rate of revision surgery over a six-year period of close to 50%. The University of Bristol reported that, overall, 6.2% of metal-on-metal hip implants failed within five years.
Patients nationwide filed lawsuits against DePuy Orthopaedics, Inc., an Indiana Corporation and subsidiary of Johnson & Johnson. Plaintiffs allege DePuy’s Pinnacle Hip Implant was defectively designed and/or manufactured and that the company failed to provide adequate warnings concerning the product.