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Shezad Malik MD JD
Shezad Malik MD JD
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The Incredible Story About Defective Metal Hip Implants

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Over the past several years I have been commenting about the incredible number of metal on metal hip implant replacement failures. The epidemic of premature metal on metal hip implant failure continues surge at an alarming rate. According to experts, all metal on metal hips will eventually fail prematurely, it is not a question of if but when.

Hip replacement surgery (hip arthroplasty) has helped millions of people overcome painful degenerative arthritis, hip fractures and improve their mobility. Unfortunately, hip metal implants are not risk free or without side effect complications. Many hip implant patients have suffered premature implant failure and other serious complications associated with their hip replacement.

There are three types of hip replacement surgery. With total hip replacement, the entire hip joint, ball and socket, and femoral stem is replaced. Partial hip replacement requires only the ball or femoral head to be replaced. In a hip resurfacing procedure, only the cup is replaced and the ball is reshaped and covered with a metal cap.

All of these hip implant procedures have the same side effect complications. The most important complications associated with these procedures are due to the metal materials of the implant components.

All Metal Hip Implants Are Susceptible to Early Failure

DePuy ASR, DePuy Pinnacle, Biomet M2A Magnum, Smith and Nephew Birmingham and R3, Wright Profemur and Conserve, Zimmer Durom cup and Stryker Rejuvenate and ABG II and Encore, are among hip replacements that continue to fail prematurely and require painful and risky revision surgery.

The leader in hip manufacturing world wide is the pharmaceutical and medical device giant, Johnson and Johnson, the parent of DePuy Orthopedics, the maker of DePuy ASR and Pinnacle.

FDA Created the Metal Hip Debacle

The metal on metal hips by these manufacturers were approved for distribution in the United States by the FDA under its 510(k) approval system. This means that it was not tested prior to release, since similar products already existed on the market. The FDA created this loophole for rubber stamping the approval for similar devices without adequate testing.

Incredibly enough, there is no national based monitoring system for hip implants, so when the early reports of premature hip failures began to bubble up in the medical circles, the companies blamed the doctors for using poor technique or patient factors. The defective hip devicesĀ  only came to light after experts in Europe, Britain and Australia noticed a connection between their metal hip implants and early failure. By the way these countries have a national data bank of hip implants.

All the hip manufacturers had to demonstrate before being approved was that they were substantially similar to pre-existing products. And what did these corporations do? They fully exploited this fast track, and there was a rush to the market in the early 2000’s to grab market share. The market was flooded by defective hip implants, and orthopedic doctors and hospitals were courted by the hip manufacturers with kickbacks and rebates to become their preferred provider.

As a result, thousands of patients were implanted with these defective hips, the implants began to fail on mass and now we are left with a tremendous mess that will reverberate throughout the next decade. What a shame, a totally avoidable scenario, that was created by the regulators, exploited by the manufacturers in their lust for corporate profit, on the backs of the patients and the taxpayers. The same old story of putting profits before people.

DePuy ASR Settlements

DePuy faces thousands of state and federal lawsuits over its ASR and Pinnacle hip implants. The ASR cases were consolidated in a multidistrict litigation in the U.S. District Court for the Northern District of Ohio, and the Pinnacle cases were consolidated in the U.S. District Court for the Northern District of Texas. Plaintiffs allege that both devices were defectively designed and that DePuy failed to provide adequate warning of safety risks.

In November 2013, Johnson & Johnson agreed to settle 7,500 ASR hip replacement lawsuits for about $250,000 per claim. The Pinnacle claims have not settled and continue to be litigated in federal court in Dallas, Texas.

What is the Problem with Biomet Metal Hip?

The Biomet M2A-Magnum Hip is a metal-on-metal hip replacement system that has been implanted in many patients throughout the United States. It was advertised heavily for being the hip of choice for active and younger patients, and according to experts, the new hip problems after implantation suggest that the metal hip implant may be susceptible to early failure within a few years of surgery.

In early 2014, Biomet announced a global settlement to cover the lawsuits claims.

Biomet M2A Magnum Metallosis

Most hip implants consist of components made of metal and plastic, but the Biomet Magnum’s claim to fame is that it has three all-metal components, a metal femoral head, metal taper insert and metal acetabulum cup. Unfortunately as these metal components grind against each other, metal debris is released into the hip joint, which causes inflammation, loosening, bone loss and destruction and problems associated with metal hip poisoning, known as metallosis.

The hips are made out of Cobalt and Chromium metal alloy and according to experts, there have been significantly elevated levels of these heavy metals, causing the injuries described above.

Stryker Rejuvenate and ABG II Hip Failure

Howmedica Osteonics Corporation, which the parent of Stryker Orthopaedics, recalled the Stryker Rejuvenate Modular Primary Hip System and the Stryker ABG II modular neck hip system in the United States in June 2012. Stryker began selling these hip systems in late 2007.

Why Were These Stryker Hip Replacement Systems Recalled?

Stryker’s Rejuvenate and ABG II modular-neck hip stem systems contain components made of chromium, cobalt, and titanium. Grinding action by the normal movement of the Stryker components causes metallosis. Metallosis caused these Stryker hip implants to fail prematurely. Stryker is now settling claims by patients that had the defective device implanted and that had the device removed and replaced.

Stryker Hip Recall Settlement

On November 3, 2014, Stryker announced a settlement of the lawsuits involving patients whose Rejuvenate or ABG II hip replacement systems were revised prior to November 3, 2014. This settlement was valued at over $1 billion.

Osteolysis Bone Loss

Osteolysis, or periprosthetic osteolysis, is the medical term for the loss of bone around the hip replacement. Osteolysis is the most common long-term hip replacement complication, and is instrumental in 75 percent of all hip implant failures.

Osteolysis occurs when the body attacks the implant debris and attempts to remove the particles. This leads to a chronic inflammatory condition and the absorption of the hip joint.

Medical Studies and Metal on Metal Hips

Some of the recent studies and advisories regarding metal hip replacements include:

  • February 2012: British Medical Journal advises that patients should be monitored annually for signs of metallosis for as long as they have a metal hip implant.
  • March 2012: The Lancet medical journal concludes that metal-on-metal hips should not be used at all due to serious issues with the safety of the implants.
  • May 9, 2012: Health Canada, the Canadian national health regulatory agency, issues a warning that patients should be aware of metal hip replacement problems and adverse effects.

The FDA has received almost 17,000 reports of adverse events from metal-on-metal hips from 2000-2011.

Biomet Magnum and Other Metal-on-Metal Hip LawsuitsBiomet is the manufacturer of the second-most widely used total hip implant system, according to the July 12, 2012, edition of the Chicago Tribune. Johnson & Johnson manufactures the number-one most widely used hip implant, the DePuy Pinnacle.

J&J, Stryker, Smith and Nephew, Wright Orthopedics, Zimmer and Biomet are defending against product liability lawsuits, which allege that their metal-on-metal hip replacement systems caused severe personal injury.