DePuy (pronounced DePew) Orthopaedics is proud of its 200 products, but three of those products could cost the company billions of dollars. The Pinnacle Hip Replacement System, the ASR XL Acetabular System total hip replacement and the ASR Hip Resurfacing System all were designed to accommodate the active lifestyle of younger hip replacement patients by providing more flexibility and range of motion than existing hip replacement devices.
That is, they were supposed to eliminate the problem of device failure because of overuse. One of the features of the systems – metal-on-metal construction – was supposed to help the failure rates. Instead, studies show the construction creates other, more serious problems.
The metal-on-metal hip systems have inherent problems with their design, leading to an increased failure rate, metallosis, infection, dislocation and immobility. Some people have begun talking about an increased cancer risk.
DePuy, a division of Johnson & Johnson, has recalled some of its hip systems. Others, like the metal-on-metal version of the Pinnacle system, were discontinued but not recalled.
DePuy’s Pinnacle Hip Replacement System
|The Pinnacle, which was approved by the U.S. Food and Drug Administration (FDA) in 2000, comes with several options for the ball-and-socket surfaces, including:|
The reason for so many options for bearing surfaces – the surfaces in which the head replacement for the thigh bone and the cup replacement for the hip socket rub together – was to allow a surgeon to select a model according to the individual needs of the patient receiving the hip implant.
The more durable the material that these components were made from, the more they supposedly could withstand use by increasingly younger patients without failing prematurely.
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Pinnacle Metal-on-Metal Acetabular Cup Metal Liner
The Pinnacle Metal-on-Metal Acetabular Cup Liner is a metal liner that was designed for use only with Pinnacle Acetabular Shells and 28mm cobalt-chromium-molybdenum (Co-Cr-Mo) femoral heads. The Pinnacle metal liner was approved by the FDA based on a nearly identical DePuy product already approved – the Ultima Metal-On-Metal Acetabular Cup, a device with a metal liner and shell.
However, the Pinnacle metal-on-metal system generated adverse reactions in patients, and so did the Ultima. Doctors from the UK published a study on the failure rate of the Ultima metal liner in 2010 and found that out of 545 patients who used the Ultima, 90 hips (13.8 percent) in 82 patients were revised after they failed. During revision surgery, doctors found cloudy fluid in pockets in the hip, severe necrosis (tissue death) and ruptured tendons.
Doctors are also tracking groups of patient who received the Pinnacle and estimate that more than 10 percent of the devices will fail in the next two to three years.
The Pinnacle and Ultima metal liners cause friction between the cup and the ball-shaped replacement head of the thigh bone. This can cause the device to prematurely erode and release metal ions that have short-term side effects and possible long-term effects.
Over the short term, the cobalt and chromium particles that are released can cause inflammation in the joint. That results in pain and difficulty of movement. Long term, possible adverse side effects include cobalt poisoning, which could cause cognitive and cardiac damage. Despite these known issues with the Pinnacle system, DePuy never recalled it. Instead, the metal liner was discontinued in mid-2013.
DePuy’s ASR XL Acetabular System Recalled
The DePuy ASR XL Acetabular System total hip replacement and ASR Hip Resurfacing System were used in more than 93,000 hip replacement surgeries internationally. Both systems were members of a class of large-diameter hip resurfacing and replacement devices created from a single sheet of metal. They were designed to be more stable, making them less prone to dislocation.
Launched in the United States in 2005, the ASR XL System was developed for use in total hip replacements. The DePuy ASR Hip Resurfacing System, which was sold only internationally beginning in 2003, was intended to be used in hip resurfacing, which eliminates the need to remove a lot of the natural hip structure.
DePuy issued a recall in August 2010 of both ASR hip systems, citing a higher-than-normal failure rate of the devices. Unfortunately, five years following implantation of the DePuy ASR hip systems, 40 percent of patients could require a second hip replacement surgery to fix problems with the first device. That’s according to evidence presented at the first ASR trial in early 2013.
Complications Associated with Metal-on-Metal Hip Implants
An increasing number of patients who received a DePuy hip implant have experienced serious complications after their initial hip replacement surgery.
|Examples of these complications include:|
|Loosening of the implant within the body.|
|Bone fracture near the implant site.|
|Dislocation of the implant so that its components are no longer properly aligned.|
|Metallosis (metal poisoning).|
These complications led to a second surgery – called revision surgery – in a large number of patients. The chief reason for removing ASR systems is the eroding of the ball and socket components, which rub against each other over time. This erosion unleashes minuscule metal particles that result in fluid collection in the joint and the muscles around the joint in many patients. The fluid collection creates swelling that causes pain and difficulty walking.
|Additional ASR implant complications that result in revision surgery include:|
|The implanted device doesn’t stay attached to the bone in the correct position.|
|The bone around the implant breaks.|
|Dislocation of the two parts of the implant.|
Conflict of Interest between Surgeons and Device Manufacturers
In a special repost published in the Archives of Internal Medicine, researchers examined data from a Department of Justice settlement with five major joint replacement manufacturers: Biomet, DePuy, Smith & Nephew, Stryker and Zimmer.
|The researchers documented:|
|How many orthopedic surgeons received payment to use the companies’ devices|
|How large these payments were|
|The total dollar amount each company paid out|
|The proportion going to orthopaedic surgeons affiliated with academic institutions|
Approximately 1,000 of the 25,000 U.S. orthopaedic surgeons received fees for consulting, royalties on products they helped develop and payments for research and clinical study work from these five companies.
The researchers’ findings for the five companies, which spanned the years from 2007 to 2008, were as follows:
- In 2007, 1,041 payments totaling more than $198 million were made to 939 orthopaedic surgeons.
- In 2008, 568 payments totaling more than $228 million were made to 526 orthopaedic surgeons.
- The number of surgeons who had academic affiliations who received payments increased from about 39 percent in 2007 to more than 44 percent in 2008.
In addition, researchers also looked at 2009 and 2010 disclosures from DePuy, one of three firms that continued to release information on a voluntary basis. They found that not only did the number of payments to surgeons increase in those years, but so too did the percentage given to surgeons with academic affiliations.
DePuy ASR and Pinnacle Hip Implant Lawsuits
Thousands of implant recipients who experienced pain, swelling, nerve, muscle and bone damage, or blood poisoning after receiving a DePuy hip implant are suing, claiming the product design was defective.
More than 8,300 ASR cases have been grouped together in federal court as part of a multidistrict litigation (MDL). The cases are being overseen by Judge David A. Katz in the U.S. District Court for the Northern District of Ohio. Thousands of additional ASR cases are pending in state courts. According to a November 2013 Bloomberg report, parent company Johnson & Johnson will pay $2.5 billion to settle 7,500 of the ASR cases.
More than 4,000 claims related to the Pinnacle hip system are included in an MDL in the U.S. District Court for the Northern District of Texas under the supervision of Judge James E. Kinkeade. The first trial is scheduled for September 2014.
Patients should speak with a qualified attorney about possibly filing a legal claim. The lawyer can discuss your compensation options from the lawsuit settlement and oversee your case through trial, if required. Financial help may be available.