Hip Replacement Recall Info

If you or someone you know has undergone hip replacement surgery, received a metal hip and currently suffering from complications of that surgery, you might be entitled to a settlement amount. There is an ongoing hip replacement recall on DePuy's ASR hip devices.

Depuy Orthopaedics has issued a recall for their defective replacement hips and this hub will provide you with all the information and updates you need regarding this hip replacement recall.

To know more about the recall and lawsuits visit the DePuy Hip Replacement Lawsuit Website.

The Food and Drug Administration’s (FDA) guidelines issued on December 13, 1984 standardized how and when manufacturers of faulty medical devices must notify the FDA about malfunctions, serious injuries or deaths associated with their devices.

The FDA’s Medical Device Reporting (MDR) guidelines regulate hip replacement failure, faulty heart valves and implants, defective knee replacement devices, and virtually all medical devices designed for implantation into the human body. In 1990, Congress passed the Safe Medical Devices Act (SMDA), which allows the FDA to monitor medical devices after receiving clearance for use. The agency also allows device tracking, which allows it to trace certain devices to individual patients who have had them implanted.

The SDMA requires “user facilities” or any medical facilities where physicians surgically implant these devices into patients, to report the following:

* Any deaths caused by a device to the manufacturer and the FDA

* Any serious injuries caused by device to the manufacturer or the FDA if the manufacturer is not known

* An annual summary to the FDA of all reports submitted by that facility

The SDMA also requires the FDA to issue regulations that require medical device distributors to report any deaths, injuries or malfunctions in connection with the devices they provide to user facilities.

Manufacturers’ Responsibilities to Report Hip Replacement Failure

Under FDA guidelines, hip replacement device manufacturers must report the following when and if they occur:

* Within 30 days of becoming aware of an event involving deaths, serious injuries or malfunctions, they must report the event(s) and continue providing reports every 30 days

* When events occur that require remedial action to “prevent an unreasonable risk of substantial harm to the public health,” they must notify the FDA within five days of becoming aware of the event and continue to provide reports every five days.

User Facilities’ Responsibilities to Report Hip Replacement Failure

Hospitals, outpatient clinics and other “user facilities” where medical devices are implanted into patients are also required to adhere to FDA guidelines. They must alert the FDA and the device manufacturer:

* Within 10 working days when a death occurs in connection with a device; and
* Within 10 working days if a serious injury occurs in connection with a device.

User facilities must also issue an annual report to the FDA that outlines all death and serious injury reports they provided that year.

These FDA guidelines are essential for protecting all citizens from defective medical devices and improper device installation procedures. They also help manufacturers and user facilities by providing clear instructions on what to do when an event involving a device occurs, what forms to use and how often they must keep the FDA updated on the situation. For more information about these guidelines, please visit http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/PostmarketRequirements/ReportingAdverseEvents/default.htm.

For over two years, hundreds of doctors and patients in the United States have been complaining to the FDA about the hip replacement implants from the Johnson & Johnson company, DePuy Orthopedics. There were countless of complaints stating that the DePuy hip replacement implants are failing much earlier than it was supposed to. From 2007 to 2009, there were already more than 400 complaints sitting at the desk of the FDA. Just recently, Johnson & Johnson finally issued a recall of the failing hip implants.

The failure of the hip implants obliged patients to undergo a second hip replacement procedure not long after the first one, which required an extremely expensive and a more painful operation. But even before the DePuy hip replacement implant issue has concluded, Johnson & Johnson faces yet again another issue related to another medical device.

In addition to the recall for the DePuy hip replacement devices, the FDA just recently criticized the company in a warning letter. In the letter, the FDA pointed out that Johnson & Johnson had illegally marketed an unapproved knee device and had also sold a hip implant for an unapproved use. This new concern makes it seem like it is pile-on time for J & J. A lot of experts in the medical field are getting alarmed by this. Johnson & Johnson used to be the company that was the gold standard when it comes to high quality medical devices, but all of sudden it seems like things are falling apart for the medical-device giant.

In the latest statement released by DePuy, they said they were recalling two products – the ASR XL Acetabular System which is a hip socket used in traditional hip replacement, and the ASR Hip Resurfacing System which is a partial hip replacement that involves placing a metal cap on the ball of the femur, which aims to preserve more bone.

With number of recalled Johnson & Johnson products increasing by the day, even including children’s Tylenol and Acuvue contact lenses, the company is giving the impression of being downright negligent. The company said it is willing to pay “reasonable and customary medical costs” caused by their flawed products. This inspired another concern – who will pay for the other costs that patients are enduring because of the problems caused by their recalled products such as lost wages, unnecessary pain and suffering, and additional rehabilitation?

A Timeline of the “Catastrophic Failure”

The recalled replacement hips manufactured by Johnson & Johnson/DePuy Orthopaedics did not become defective overnight. The evidence suggests that J&J has known for years that the products were defective. Key dates and events include the following:

• 2005: J&J/DePuy introduces the ASR hip replacement system in the United States after winning a “510(k) clearance” from the Food and Drug Administration (FDA). Such clearance meant that the product was given regulatory approval without having to go through clinical trials.
• 2008: A report to the Medicines and Healthcare products Regulatory Agency (MHRA; the British equivalent of the FDA) finds “evidence of genetic damage in patients with certain metal hip implants” (such as the ASR system).
• 2008: The FDA receives 400 complaints from or about patients who had ASR devices installed. 13% of ASR hip replacement patients require a second surgery to replace the device(s)—a much higher failure rate than the industry standard.
• 2009: DePuy voluntarily withdraws the ASR system from the Australian market.
• 2010: J&J/DePuy announces that it will phase out sales of the ASR hip replacement system by the end of the year. The companies send letters to doctors warning that data from the Australian Medical Device Registry show a higher than expected failure rate of the ASR system, especially in smaller patients or those with weak bones.

J&J/DePuy continue to sell the defective ASR even after being warned for years by surgeons of the device’s problems.

• May 2010: The London Times reports that “[MHRA] announced an official review in April of some 40,000 hip replacements. Doctors are warning that metal debris originating from the defective implants can cause non-cancerous tumors, severe swelling and sinew damage.”
• March 10, 2010: The New York Times reports that DePuy has warned doctors that its ASR system was failing patients within a few years after the replacement suregery, when such implants should typically be expected to last 15 or more years. To some this was considered a “silent’ recall.
• June 15, 2010: Kathleen Margunau, a Florida woman, files the first lawsuit against DePuy for harm caused by the ASR system. The suit, filed in federal court in Ft Myers, claims that Ms. Margunau received a DePuy ASR acetabular cup in March 2008 and began experiencing “extreme weakness in her hip and quadriceps” following surgery. Less than one year later, she required a second surgery, during which doctors, after removal of the hip implant, found that the device had catastrophically failed.
• July 17, 2010: The FDA notifies the public that DePuy is recalling its ASR hip implant cups (FDA recalls nos. Z-2031 through Z-2059-2010).
• August 26, 2010: J&J/DePuy issues a worldwide recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System. The decision is the result of a determination that the failure rate for both systems was over 12%.

Because of the controversy it has created, experts have come up with a list of symptoms that will if your DePuy hip replacement implant is failing prematurely. However, you need to know the basics of hip surgery first to avoid confusion or paranoia.

The primary reason why people go through hip replacement surgery is the wearing down of the hip joint, which usually an offshoot of osteoarthritis. However, there are other medical conditions that can lead to the deterioration of the hip joint hence the need for a hip replacement surgery.

These include:

• Rheumatoid arthritis, which is the chronic inflammatory disease that causes pain in the joints as well as stiffness and swelling.
• Avascular Necrosis, which indicates bone loss due to insufficient blood supply.
• Injury and bone tumors

Before resorting to a hip replacement surgery, a doctor will likely recommend trying walking aids like a cane, or non surgical options like medication and physical therapy. However, these therapies are not always effective in relieving pain and improving the function of the hip joint. Hip replacement is perhaps the best option if you are feeling a persistent pain or experiencing disability performing your daily activities. But, there should be an apparent joint damage in the hip detectable on x-rays for a doctor to finally recommend pushing through hip replacement.

Symptoms of a Failing DePuy Hip Replacement Device

Extensive research revealed the following classic symptoms associated with a malfunctioning DePuy hip replacement implant. Patients and doctors have reported that:

• There is a continuing hip, groin, leg, and lower back pain
• There is an audible clicking, clicking, or a crunching sound that comes from the DePuy hip replacement implant
• There is a strange feeling that one’s hip is dislocated or is “not in its proper place”, especially during movement – like standing up or starting to walking
• There is a significant decline to perform physical activities
• There is an increased metabolic activity near the area where the DePuy hip replacement device is implanted, as indicated in the bone scan.

While these symptoms are present in 9 out of 10 cases of failed DePuy hip replacement implants, treating physicians are not yet able to make a definitive diagnosis of the ASR acetabular cup failure sans the revision surgery.

If you have had a DePuy hip replacement implant and are experiencing any of these symptoms, you may qualify for compensation as far as physical damage, additional surgeries as well as your pain and suffering are concerned. Consult an attorney who is experienced at handling this kind of cases before contacting DePuy Orthopedics or Johnson & Johnson. It is very important that you know your rights.