Sullo & Sullo - Product Defect Blog

Titanium Hip Replacement Recall: Titanium Effects on Stryker Rejuvenate Hip Implant Recipients

Jun 15

Saturday, June 15, 2013  RssIcon

Following the recalls of metal-on-metal hip replacements, most of us are aware of the potential hazards related to the implant parts which are constructed of cobalt and chromium. Metal poisoning can occur when the metal components rub against one another, causing tiny metal ions to shear away and enter the surrounding tissues and/or the bloodstream. Many recipients of all-metal hip implants—like the recalled Stryker Rejuvenate and ABGII—have ended up with serious health issues from the toxic effects of cobalt and chromium in the body.


What about Titanium Effects?

Much less is known about the effects of titanium in the body. The stem of the Rejuvenate is made of titanium which is not nearly as hard as cobalt and chromium and offers a bit more flexibility in that particular area. Metal allergies are fairly common—at least 30 percent of all people have a metal sensitivity to nickel which is found in small amounts in cobalt and chromium. Titanium allergies are barely recognized in mainstream medicine yet labs which are now using a technology known as MELISA® report that some 4% of all patients tested for titanium sensitivity will test allergic to the metal.


Symptoms of Titanium Allergies

Those who are allergic to titanium may suffer from vague symptoms of skin rashes, muscle pain and fatigue, yet because titanium testing is still in its infancy, few physicians test their patients for titanium allergies. Titanium is considered an “everyday” metal, used in a wide variety of applications aside from hip implant components including food, cosmetics, sunscreen, medicine, paint, plastic bags, some brands of whitening toothpaste, jewelry, vitamin supplements and to rebuild bones following an accident. In fact, several brands of candy including Skittles and M & M’s are coated with titanium dioxide.


Titanium and Corrosion of the Stryker Rejuvenate

Titanium, like all metals, will release particles when corrosion occurs, sending those metal ions into the body to bind with body proteins. The body of a person who is allergic to titanium will attempt to attack the titanium ions in the body which begins a chain reaction and can lead to many adverse symptoms including Chronic Fatigue Syndrome. The MELISA® test is currently the only test which has been scientifically proven to diagnose titanium allergies, measuring their severity in the process. Further, several studies have shown that the metal titanium is frequently polluted with traces of nickel as a result of the production process which can trigger health problems in those with nickel allergies.


Clinical Studies Regarding Hypersensitivity to Titanium

One article, Hypersensitivity to titanium: Clinical and laboratory evidence, published in 2006, tested fifty-six patients who had developed troubling health symptoms following a titanium-based metal hip implant. The patients were tested for allergies to ten metals, including titanium; 37.5% tested positive for a titanium allergy, 28.6% had tests which were “ambiguous” and 33.9% tested negative. Fifty-four of the fifty-six patients had their titanium-based metal hip implant removed and 100 percent showed remarkable clinical improvement of their earlier symptoms. The article concluded that the metal titanium can induce “clinically relevant hypersensitivity in a subgroup of patients exposed to titanium implants.”


The Journal of Bone and Joint Surgery published an article in 2004 titled Pain in the well-fixed, aseptic titanium hip replacement. Nine patients with titanium hip replacements presented with early pain despite a well-fixed implant with no infection. The pain was universally located in the thigh and was worse at night among all nine patients. X-rays showed hypertrophy of the femur around the tip of the stem and eight of the nine patients required revision surgery using an un-cemented hip implant which relieved the pain of all eight patients. At the time of the revision, the PH tip of the stem was found to be highly acidic with evidence of corrosion leading to the conclusion that cemented titanium implants have the potential for crevice corrosion which leads to hypertrophy and intractable pain. This particular article also notes that galvanic corrosion can occur in modular hip implant systems in which different metals come into contact.


Requesting a MELISA® Test When Titanium Allergies are Suspected

Even though titanium components have been used for over three decades in hip implants, titanium tests were never even considered as titanium is generally considered a “safe” metal. It appears that those with a hip implant which has a titanium component should consider titanium sensitivity should they develop skin rashes, muscle pain, fatigue, thigh pain or Chronic Fatigue Syndrome. There is no research as yet to determine whether the titanium might react negatively with cobalt and chromium when the ion debris from both components mixes together and enters the body. It’s important to consult with a physician should any negative or unusual symptoms appear following an all-metal hip implant such as the recalled Stryker Rejuvenate or ABGII. The titanium hip replacement recall of the Rejuvenate and ABGII took place in July, 2012, and lawsuits have been steadily mounting since that recall.

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