DePuy Orthopedics invented both the Pinnacle implant and the ASR hip implant to meet the requirements of a younger group of patients who wished to be more active after a hip replacement surgery. Those who received this new generation of hip implants turned out to not be so lucky. Corrosion of the metal hip implant components has caused metallosis (toxicity in the body caused by dissolved metal ions) to many of the patients. The construction of these metal–on-metal devices was expected to be more durable than earlier products, but has shown significant failure rates including infection and a decrease in mobility.
The DePuy Pinnacle Implant
The U.S. Food and Drug Administration (FDA) approved the use of the Pinnacle implant in 2000, which involved several different product combinations, including metal-on-polyethylene, ceramic on ceramic, ceramic on metal, ceramic-on-polyethylene and metal-on-metal.
This large choice meant the surgeon undertaking the work could choose from a number of different materials depending on the situation and age of individual patients. The device that has caused the most problems is the metal-on-metal Acetabular Cup Liner which was designed to be used with a Pinnacle Acetabular Shell and a chromium-cobalt–molybdenum 28mm femoral head. The FDA approved the Pinnacle metal liners based on a similar DePuy product which had already received approval. This was the Ultima Cup, a product with a metal shell and liner and the metal-on-metal Acetabular.
Adverse Reactions to DePuy Products
Unfortunately for its recipients, the Pinnacle metal-on-metal products and the Ultima Cup brought about adverse responses in patients. Data on the failure rates indicate there is an approximate 10 percent chance the product will fail in the two to three years after implant.
The Ultima and Pinnacle metal liners encourage friction to take place between the cup and the ball-shaped replacement head of the thigh bone. This can cause premature erosion and the release of metal ions, causing both short and long term negative effects. Any chromium and cobalt particles which have been released may cause joint inflammation leading to impaired movement and cobalt poisoning. This may result in cardiac and cognitive damage.
The ASR XL Acetabular System
This DePuy complete hip replacement product, the ASR XL Acetabular System and the ASR Hip Resurfacing System, dominated 93,000 hip replacement surgeries globally. Both of these systems were large-diameter hip replacement and resurfacing devices formed from one metal sheet and were being marketed for their stability. They were designed to be more stable, making them less prone to dislocation. They had to be recalled eventually because of their abnormally high failure rate, meaning patients had to schedule another hip replacement surgery.
Lawsuits for Flawed DePuy Pinnacle and ASR Implants
There are over 8,600 ASR hip implant cases facing the federal court under multidistrict litigation (MDL). DePuy’s parent company, Johnson & Johnson, was willing to pay $2.5 billion in order to settle 7,500 ASR cases. At least 5,400 of these claims were due mostly to the Pinnacle hip system and were part of an MDL in 2014 filed at the U.S. District Court for Texas’s Northern District.
Those who have been affected by the DePuy or ASR hip implant products are entitled to reimbursement for their losses. Revision surgeries, medical expenses, lost wages, pain and suffering, and other implant related damages will help provide reimbursement to the victims. Our hip implant lawyers are available to discuss your legal options at your convenience by calling (314) 409-7060, or toll-free at 855-55-BAD-DRUG.
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