On August 24, 2010, DePuy Orthopaedics, a subsidiary of Johnson & Johnson, issued a voluntary worldwide recall of their ASR Hip Resurfacing System and ASR XL Acetabular System after receiving information about a high number of device failures, complications and painful symptoms. Between 2003 and 2010, more than 93,000 patients underwent hip replacement surgery using ASR prosthetics manufactured by DePuy Orthopaedics. According to official estimates, one in every eight patients implanted with recalled DePuy devices will experience complications and pain requiring revision surgery and ongoing testing.
In total hip replacements, the femoral head and the acetabulum socket located in the pelvis are replaced with a prosthetic ball and cup. Components of the recalled DePuy hip implants are made with a combination of cobalt and chromium, which can abrade during normal use and release dangerous particles into the bones, soft tissue and bloodstream. The ball and cup of these devices are designed to be separated by a thin layer of fluid. Due to the shallow design of the recalled hip cups, the ball is prone to riding out of the cup where it catches on groves in the prosthetic surface. This dislocation of the metal ball and cup compromises the protective layer of fluid and can cause metal particles to infiltrate the surrounding tissue.
Common symptoms related to recalled DePuy hips include pain when bearing weight, acute pain in the hip and groin when sitting, standing or changing position, decreased mobility, general pain, swelling, audible grinding noises and elevated metal levels in the blood. In some cases, defective implants will become dislocated, loosen from the bone surface or cause fractures in the surrounding bone. Other symptoms and side effects include pseudotumors, a reaction to foreign metal particles, metallosis, and asceptic lymphocyte-dominated vasculitis associated lesions (ALVAL), which is another adverse condition affecting the soft tissue. Microscopic metal particles are extremely dangerous and are known to cause painful inflammation and damage to bones, muscles and soft tissue.
While symptoms related to recalled DePuy hips are often debilitating and therefore obvious, other health conditions can be difficult to pinpoint. Patients who received recalled DePuy hip implants but are not experiencing pain are urged to consult their physician. Periodic blood tests monitoring the presence of metal ions in the blood are vital for detecting problems before they are exacerbated. Under the company's voluntary recall, DePuy and Johnson & Johnson are assuming financial responsibility for revision surgeries and ongoing tests to monitor metal levels in the blood.
Recalled DePuy ASR hip implants were marketed to young and active patients. According to the manufacturer, the recalled ASR devices were expected to last patients 15 to 20 years. In patients, more than 13 percent of ASR hip implants failed within five years, and approximately 30 percent of all ASR implants are expected to fail. Accordingly it is extremely important that hip transplant patients know whether or not they were implanted with a DePuy device that has been recalled and to monitor closely any problems associated with that device.
If you have questions regarding the recall of DePuy hip implant devices, or medical or legal questions regarding those devices contact us today. Our Patient and Family Advocates can steer you to the best available help.