Practice Area: Defective Drugs & Medical Devices


DePuy Hip Replacement Failures

DePuy Orthopaedics, a subsidiary of Johnson & Johnson, announced at the end of August 2010 that it is recalling parts used for hip replacements. At issue is the high rate of repeat surgeries needed by people who have received the implants. An estimated 93,000 people will be affected by Johnson & Johnson’s latest product recall. Following many months of pain, inconvenience and rehabilitation therapy for hip replacement surgery with the DePuy ASR hip replacement system, one in eight patients will be forced to undergo the ordeal again due to defects in the ASR system, according to MHRA reports.

The hip implants have been associated with pain, infections, fractures, dislocation, sensitivity to the metal and loosening of parts. DePuy has announced that 12 percent of patients who received the ASR resurfacing device and 13 percent of patients who received the ASR total hip replacement need a revision surgery. Revision surgery is a painful and expensive process in which the defective ASR cup is removed and replaced with a different device. It is a surgery to replace defective parts.

Which DePuy Replacements Are Involved?

Affected hip replacement parts involved in the recall include the DePuy ASR XL Acetabular System, which is the cup portion of a replacement hip joint, and the DePuy ASR Hip Resurfacing System. Resurfacing involves implanting a cup and capping the ball at the top of the thighbone in a procedure that preserves more bone than traditional replacements. It is geared toward younger patients.

Each of the metal products is used to replace a worn or weakened part of the hip, which consists of a socket at the outer edge of the pelvis and a rounded bone atop the thigh bone that fits into that socket like a ball. The ASR Hip Resurfacing System replaces the ball portion of the hip and has a metal stem that fits into the top of the hip bone, or femur. The ASR XL Acetabular System is a concave metal piece used to provide a smooth lining for the acetabulum, the bowl-shaped socket in the pelvis.

Is Replacement Necessary?

DePuy’s hip resurfacing product, a form of hip replacement arthroplasty, is designed to provide patients with an alternative to total hip replacement where less bone could be removed and fewer hip dislocations occur. Unfortunately, those benefits are greatly outweighed by the dangers of DePuy’s defective hip replacement.

Although this August 26, 2010, DePuy hip recall is voluntary, DePuy also received a warning letter from the FDA that charges the company with marketing some other joint replacement products without required approval.

Physicians were notified about potential problems with the hip replacement parts beginning in March of ??. The decision to recall the parts was made when the results of a new study confirmed a five-year rate of revision surgery of about 12 percent for the ASR resurfacing system and about 13 percent for the ASR XL system, according to DePuy, which is higher than the expected rate.

What Symptoms And Issues Are There With These Devices?

Patients who reported problems in the first five years and had revision surgery reported a variety of symptoms, including pain, swelling and problems walking. These symptoms are normal for patients following a hip replacement, but can be a sign that something is wrong if they continue or come back frequently. These symptoms may indicate serious problems, including:

Loosening — when the implant does not stay attached to the bone in the correct position

Fracture — where the bone around the implant may have broken
Dislocation — where the two parts of the implant that move against each other are no longer aligned

One of the greatest dangers of these products is the elevated levels of cobalt and chromium which can affect people in a number of ways, and which have been identified by English doctors as unsafe. DePuy does not provide sufficient information to its consumers about ion levels, so it is important that you seek guidance regarding your personal situation.

According to published reports, DePuy has stated it will cover “reasonable and customary costs of monitoring and treatment for services,” but DePuy has limited its voluntary offer of compensation to the costs of medical care provided.


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