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Defective Hip Implants

Defective Hip Implants

DePuy Orthopaedics, owned by Johnson & Johnson, has issued a voluntary recall of its ASR hip implant devices. According to the company, the patient revision surgery rate is double that of the industry average. A new unpublished study from the National Joint Registry of England & Wales (NJR) discovered that one in eight patients who received the ASR hip implants required a second or revision surgery five years after they received the implant.

The recall comes amid a string of quality-control problems at the company’s non-prescription drug operations and includes the ASR XL Acetabular System and DePuy ASR Hip Resurfacing System. At least 12 to 13 percent of patients who received the DePuy ASR hip implant devices have required a second surgery.

What are DePuy ASR Hip Implants?

The ASR XL Acetabular System and the ASR Hip Resurfacing System are both artificial hip implants manufactured by the DePuy Orthopaedics unit of Johnson & Johnson. The Hip Resurfacing System has been available since 2003 for use outside the United States, whereas the Acetabular System has been in use around the world since 2004. DePuy took both ASR hip implant devices off the market in 2009.

What are DePuy Pinnacle Hip Implants?

The Pinnacle hip replacement system is also manufactured by the DePuy Orthopaedics unit of Johnson & Johnson. The Pinnacle artificial hip replacement system was approved by the U.S. Food and Drug Administration in 2000. It has a ball and socket design that features several different types of surface designs including ceramic-onpolyethylene, ceramic-on-ceramic and metal-on-metal.

The various options for bearing surfaces was developed to allow surgeons and their patients to select a model according to the needs of the patient. The more durable the material, the more they were expected to withstand the wear and tear of younger patients.

However, like its sister product, the ASR replacement, the Pinnacle metal-on-metal model can cause the same dangerous conditions like hip pain, problems walking or standing, loosening of the replacement or metal poisoning.

Symptoms

According to the DePuy site and several articles, patients experiencing DePuy hip implant failures include one or more of the following symptoms:

  • pain
  • necrosis
  • infection
  • inflammation
  • nerve damage
  • tissue damage
  • muscle damage
  • limited mobility
  • component loosening
  • component misalignment/dislocation
  • soft tissue masses/non-cancerous tumors
  • fracture of the bone around site/weak bones
  • metal sensitivity/metal contamination/increased metal levels in blood

Metal Poisoning

The DePuy hip implant devices are made up of ball and socket components that move against each other. These metal components wear over time and release microscopic particles around the patient’s hip. Some patients react to these particles, causing fluid to collect in the joint and in the surrounding muscles. This condition could initially be painless. If left untreated, though, it may cause pain and swelling around the joint and could damage a person’s muscles, bones and nerves in the area.

Even if you are not experiencing these symptoms, you should schedule an appointment with your surgeon if you have a DePuy hip implant because the body’s reaction to the metal particles released by the hip implant device could be asymptomatic.

Tests will help your surgeon determine if your hip is working as it should and whether you are having a reaction to the metal particles. Your surgeon may take X-rays of your hip. Also, a blood test may be done to check the levels of metal particles around your hip. Your surgeon may also use an ultrasound or MRI to determine if you are having a reaction.

Who is At Risk

The risk of DePuy hip implant failures were especially high in women followed by patients whose femoral head (or ball) is smaller than 50mm. In addition, both implants were popular with younger patients because the devices were supposed to reduce the chance of dislocation.

The patients who reported problems in the first five years, and had revision surgery, reported a variety of symptoms. These symptoms included pain, swelling and problems walking. If your symptoms are persistent, it could be a sign of a more serious problem, such as:

  • Loosening caused when the implant does not stay attached to the bone
  • Fracture(s) where the bone around the implant may have broken
  • Dislocation caused when the two parts of the implant that move against each other become misaligned.

Timeline of Events

2005-2009 Timeline Surrounding DePuy Hip Implant Recall

  • 2005: J&J/DePuy introduces the ASR hip replacement system in the United States after a regulatory clearance allowed approval without having to undergo clinical trials.
  • 2008: The FDA receives 400 complaints from or about patients who had ASR devices installed.
  • 2008: The MHRA (British equivalent of the FDA) finds “evidence of genetic damage in patients with certain metal hip implants.”
  • 2009: DePuy sends letter to U.S. doctors, stressing importance of proper positioning of hip implants without addressing any other specific concerns.

2010 Timelines Leading to Recall

  • March 10, 2010: The New York Times reports that DePuy warned doctors that its ASR system was failing in certain weak-boned patients within a few years after the replacement surgery.
  • 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 19, 2010: FDA criticizes DePuy in a letter.
  • August 26, 2010: J&J/DePuy issues a worldwide recall of both the ASR Hip Resurfacing System and the ASR XL Acetabular System – a decision based on the over 12 percent of DePuy hip failures for both systems.
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case study

Defective Hip Implant

Multidistrict litigation (MDL) brought by Simmons Hanly Conroy resulted in a $502 million verdict against Johnson & Johnson (J&J) in a bellwether trial brought on behalf of five clients injured by J&J’s DePuy Pinnacle metal-on-metal hip replacement devices. The jury verdict awarded plaintiffs $142 million in compensatory damages and an additional $360 million in punitive damages.

Read the Case Study

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