Sunday, January 26, 2014

What Caused the Stryker Recall?


The Stryker recall of the Rejuvenate and ABGII hip implants in July, 2012, left many implant recipients extremely concerned about their health and their future. After receiving FDA approval in 2008 and 2009, both models were marketed aggressively due to their new design which allowed surgeons the ability to fit the implants more precisely, according to the activity level and body size of the individual. While marketed as being safer than other all-metal hip implants, the Stryker recall proved this to be untrue. In fact, despite the use of a ceramic ball, the Stryker Rejuvenate and ABGII may have the same level of risk as the true metal-on-metal implants. 

Because the Stryker recall was for both the Rejuvenate and the ABGII, it is widely assumed the two hip implant devices are virtually identical. While both models fell under the same Stryker recall, there are important differences as well as some similarities. Both the Rejuvenate and the ABGII implemented a cobalt and chromium neck piece and a titanium stem in a wide range of sizes and lengths. The metal juncture between the neck and stem piece was noted in the Stryker recall as having a risk of corrosion, as well as the small metal trunnions located on either end of the neck piece. 

What the Stryker recall did not detail were some differences between the two models. The primary difference between the Rejuvenate and ABGII is the hydroxyapatite porous coating; the coating of the Rejuvenate is rough and deep, encouraging the bone to grow more deeply into the coating. The ABGII coating is much smoother and shallower. As the Stryker recall noted, the risk of revision surgery due to failed hip implants is greater than normal. The ABGII hip device is considerably easier to remove; due to the shallower hydroxyapatite coating however removing the Rejuvenate can be extremely difficult as well as risky to the patient.

Prior to the Stryker recall, the manufacturer claimed the proprietary blend of titanium, molybdenum, zirconium and iron which make up the ABGII and Rejuvenate stems would resist fretting and corrosion. As evidenced by the Stryker recall, post-market data did not support that claim.  The proportions of cobalt and chromium in the ABGII and Rejuvenate are somewhat different and the Rejuvenate stem is longer.  Other than these differences, the Stryker recall applies fairly equally to both devices, and both implants are subject to fretting, corrosion and failure.

The microscopic ions which shear away into the body during times of physical activity can cause inflammation, chronic pain, and the destruction and death of tissue and bone when lodged in the hip tissue. When the cobalt and chromium ions enter the bloodstream, metal poisoning can occur, resulting in: loss of vision and hearing, DNA disruption, chromosomal abnormalities, chronic headaches, anxiety, depression, vertigo, memory loss and cardiovascular, neurological, renal, thyroid and gastrointestinal disorders—many of them quite serious. Following the Stryker recall, lawsuits against the company are on the rise, and many injured consumers are speaking to Stryker recall attorneys who can offer information, guidance and help for their future.

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Author: Andrew Sullo
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Andrew Sullo

Andrew SulloAndrew Sullo

Andrew Sullo is a National Trial Lawyer's Top 100 Selection for 2013-2018. He is also a member of the American Association of Justice.

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