DePuy ASR Hip Recall

Approximately 93,000 patients worldwide had received DePuy’s ASR (Articular Surface Replacement) hip replacement system when the voluntary recall of the implant was issued on August 26, 2010. The DePuy ASR recall came in the wake of increasing alarm over unexpectedly high rates of revision—second surgeries required to remove improperly functioning devices—made necessary by early failure of the hip implant.

Estimates indicate that the DePuy hip recall has cost Johnson & Johnson (J&J), the parent company of DePuy Orthopaedics, more than $4 billion dollars.

Impact of DePuy hip recall on patients

For patients, the cost has been financial and physical. The implant’s allegedly defective design has caused some patients debilitating problems and permanent injuries.

ASR hip complications may include:

• Severe pain
• Difficulty standing or walking
• Hip fractures or dislocation
• Tissue inflammation, infection and necrosis
• Heavy metal poisoning (metallosis)
• Crunching or popping noises
• Pseudo-tumor formation
• Implant misalignment/ loosening of the device

Internal documents obtained through litigation have revealed that DePuy estimates that four out of ten patients with the ASR hip replacement system may need second replacement surgery—“revision surgery”—because of early device failure.

Research from the United Kingdom estimated that the rate of five-year revision surgery for Johnson & Johnson’s ASR hip was from 12 to 13 percent.

Hundreds of complaints were filed with the FDA about the DePuy ASR hip systems between 2006 and 2009, with patients often complaining of difficulty walking, chronic pain and swelling. By 2009, almost 90 percent of those who reported complications eventually needed hip revision surgery to remove the implants and correct damage done by them.

Reasons for the DePuy ASR hip recall

Failure to satisfy “clinical expectations” is the official reason given by DePuy for recalling the ASR XL Acetabular System total hip replacement and the ASR Hip Resurfacing System. Compared to alternative metal-on-metal hip replacements, the ASR has a metal cup lacking depth, which could be a possible design flaw blamed for high rates of early ASR failure.

This allegedly flawed design of the ASR hip may lead to:

• Excessive friction between the metal cup and ball
• Poor implantation
• Loosening parts
• An increased risk of metallosis (heavy metal poisoning) 

Metallosis occurs when the ASR’s femoral head and the acetabular cup rub together, releasing cobalt and chromium particles into adjacent tissues and from there into the bloodstream.

The following symptoms may be signs of metallosis:

• Inflammation around the implant site
• Groin or thigh pain
• Fatigue
• Nerve palsy

The ASR Acetabular System was released in the United States in 2005 and sold worldwide. The ASR Hip Resurfacing System was released in 2003 and sold only outside the U.S.

DePuy hip replacement recall timeline

A DePuy ASR hip recall timeline of critical events includes the following:

• 2003 – Targeting a younger demographic, DePuy advertises the ASR Hip Resurfacing System to patients desiring to maintain an active lifestyle after surgery.
• 2005 – Complications due to metal-on-metal hips are revealed in medical studies.
• 2008 – U.K. orthopedic databases indicate unexpectedly high frequency of DePuy ASR hip failure in as little as 1-5 years. Artificial hips are generally intended to last up to 15 years.
• 2009/2010 –DePuy starts phasing out its ASR hips in the U.S., acknowledging unacceptably high rates of premature failure.  The company states that sales are slowing and claims surgeons are to blame for the complications, due to substandard technique while implanting the devices.
• March 8, 2010 – An “Urgent Field Safety Notice” distributed by DePuy warns of “higher than expected revision rates” linked to ASR systems.
• August 24, 2010 – The ASR is voluntarily recalled by DePuy. The company cites a U.K. database of patients showing a 13% rate of device failure within five years of implantation. DePuy categorizes the the recall as Class A, reserved for a “defective product that would affect product performance and/or could cause health problems.”
• 2013 – DePuy retracts this description during litigation, claiming the implants were not defective. 

Options for those impacted by the ASR recall

After the ASR recall, DePuy advised patients to consult with their surgeon for a post-operative evaluation, even if there were no apparent complications. Additional testing, such as blood tests for metal toxicity, ultrasounds, x-rays and MRIs could help diagnose patients with bone damage, metal poisoning or other symptoms of hip implant failure.

Those who have suffered complications, and/or needed revision surgery due to the ASR XL Acetabular System, should contact a qualified attorney to protect their rights to compensation.

DePuy may pay for revision surgery and other treatment costs concerning the ASR, but many patients have found that this limited compensation isn’t enough to meet exorbitant medical costs.

Additionally, compensation for pain & suffering is not available in DePuy’s hip recall claims system.

Through legal action, recipients may be awarded compensation for lost wages, emotional trauma, medical bills (including revision surgery costs), reduced capacity to earn wages, and other losses.

J&J is currently defending approximately 11,500 DePuy hip lawsuits.

Actions to protect patients’ rights

Patients impacted by the DePuy hip recall, and considering litigation, should consider these options:

• Before the patient signs a document or waiver from J&J or DePuy, the patient should have a lawyer review the paperwork.
• The patient should have his/her health care provider provide copies of medical records related to the ASR device and subsequent procedures. Those records should be kept in a safe place.  Copies should only be provided to his/her attorney.
• The patient should get multiple second opinions from specialists before going forward with hip revision surgery.

The patient should ask his/her physician about hip implant-related health concerns. A products liability or person injury attorney can discuss the patient’s legal rights and ability to file a legal action concerning the DePuy ASR hip and associated damages.

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