DePuy ASR Hip Recall Guide and Metallosis Risk

Over 90,000 US citizens are recipients of the recalled DePuy ASR DePuy hip implant. We think only a fraction of individuals with an ASR DePuy hip implant have been identified, because they do not want to go through the tough surgical ordeal again. Our goal is that we want to get all recipients of the recalled ASR DePuy hip implant identified, so that they get meaningful legal and medical help.

The ASR DePuy implants were widely used throughout the United States from 2005, until 2010. We are recommending every recipient, or family member of a recalled ASR DePuy hip implant to call us, if they are suffering pain, problems walking, swelling of the hip, or lack of flexibility. It has already been well documented that there is an extremely high failure rate for the ASR DePuy hip implants.

Women are reporting more problems, and a higher failure rate, with the DePuy ASR XL Acetabular hip replacement system. Women are also more likely to develop some of the serious side effects of the defectively designed implant, including metallosis.

Metallosis is a build-up of cobalt and chromium ions in the soft tissue of the body, particularly around the joints. Metallosis has been noted in people with all kinds of metal-on-metal joint implants and replacement systems. The engineering of the implant is causing far more friction, which leads to metallic debris being released into the tissue surrounding the implant.

The design of the ASR XL Acetabular system was developed to provide a greater range of motion. The DePuy engineers removed the plastic liner from the inside of the hip implant and made the acetabular cup shallow so that patients could move their legs in a wider arc.

The femoral head moves constantly back and forth as the hip implant’s owner moves normally, and that puts stress on the acetabular cup. In an implant with a deeper acetabular cup than the DePuy ASR hip implant, there is more material to accommodate the strain of motion. The force is distributed over a bigger surface, which means that the implant overall can hold up to that strain better.

The already-shallow hip implant is made smaller overall to accommodate a woman’s smaller frame. Women have naturally wider hips and larger hip sockets than men do, which means that the shallow acetabular cup becomes in effect even shallower.

And the smaller the surface area of the implant, the more likely the material will break down rapidly releasing metal ions into the body. Those metal ions accumulate in the soft tissues surrounding the hip joint, causing metallosis.

Women also more likely to see the problems that develop as a result of metallosis, including metal hypersensitivity, heavy metal poisoning (which includes chromium poisoning and cobalt poisoning) and tissue and bone deterioration.

We are DePuy ASR and DePuy Pinnacle recall attorneys and are providing this news update to the victims of Defective DePuy ASR Hips and DePuy Pinnacle Hips.

According to allegations raised in a new DePuy Pinnacle hip lawsuit filed earlier this month, the manufacturer of the implant has known for some time that it was a defective and dangerous device, and should have removed it from the market years ago.

The complaint was filed in The U.S. District Court for the District of New Jersey against DePuy Orthopaedics, Inc., Johnson & Johnson and the designer of the metal-on-metal hip replacement.

The DePuy Pinnacle hip system was introduced in 2001, with some variations containing a metal liner instead of a polyethylene liner, which can result in microscopic metal particles being shed into the body as the metal parts of the hip replacement rub against each other. This can lead to inflammation, swelling, loosening of the parts and ultimately may cause the hip replacement to fail, resulting in the need for hip revision surgery.

The companies did issue a recall for the DePuy ASR hip replacement system in August 2010, due to problems that are similar to what has been reported in connection with the Pinnacle hip. The DePuy ASR was approved by the FDA in 2005 as a “substantially equivalent” design to the DePuy Pinnacle. Post-marketing data provided at the time of that recall indicated that the DePuy ASR failure rate was about 12-13%, but some estimates suggest that nearly 50% of the recalled ASR hip replacements may lead to failure problems within six years.

In October 2010, the American Academy of Orthopaedic Surgeons (AAOS) issued a warning about potential problems with metal on-metal hip replacements, indicating that patients and the medical community should be aware that pain months after hip replacement surgery may be a sign of metal-on-metal hip cobalt toxicity. The FDA launched a new website in February to provide information about the risks associated with metal-on-metal hip replacements.

The metal ions, usually cobalt or chromium, can damage bone and tissue around the implant and joint, causing the implant to become loose or causing the patient to feel pain. The particles can have effects on the heart, nervous system and thyroid when in the bloodstream at high levels.

In the U.K., health officials recommend patients with metal-on-metal hip implants that are causing them pain be tested for metal ions in the blood, but the FDA has yet to make similar recommendations. Metal-on-metal hip implant recipients should see their orthopedic surgeon if they experience symptoms including heart pain, chest pain, shortness of breath, numbness, weakness, changes in vision or hearing, fatigue, unexplained cold, weight gain or changes in urination habits, the FDA advises.

A California lawsuit has been filed with the U.S. Judicial Panel on Multidistrict Litigation to consolidate and centralize the federal DePuy Pinnacle hip litigation in one court for coordinated pretrial proceedings, either as part of the pending DePuy ASR recall litigation or as a new multidistrict litigation (MDL). The DePuy ASR hip recall litigation is already consolidated as part of an MDL, in the U.S. District Court for the Northern District of Ohio.

The lawsuit argues that they are all related on common issues of fact, and such consolidation helps reduce duplicative discovery in different cases, eliminates inconsistent rulings from different judges and serves the convenience of the parties, lawyers and the courts. The plaintiff has requested that the Panel either designate a new court for handling of the litigation over DePuy Pinnacle hips or consolidate the DePuy ASR lawsuits and DePuy Pinnacle lawsuits in the same coordinated action.

While approximately 93,000 DePuy ASR hip systems were sold before it was removed from the market, more than 150,000 DePuy Pinnacle hips were manufactured according to the lawsuit. In addition, since the August 2010 ASR recall, more than 1,300 people have filed an adverse event report with the FDA involving problems with a DePuy Pinnacle hip.