Stryker Quietly Announces Rejuvenate Hip Implant Recall
July 5, 2012 - Stryker has announced a voluntary recall of the Stryker Rejuvenate Modular and ABG II modular-neck hip stems. The recall was made voluntarily, over concerns of potential risks associated with modular-neck stems. The Stryker website reports that the risks include the potential for "fretting and/or corrosion at or about the modular-neck junction, which may result in adverse local tissue reactions manifesting with pain and/or swelling."
Like previous metal-on-metal hip implants that were recalled, the alleged issue is an increased risk of metallosis, which occurs when metal hip components rub against one another, releasing particles of chromium and cobalt in the blood. Acording to Stryker, if you are experiencing pain or swelling at the joint site, you should speak with your hip surgeon.
Metal-on-Metal Hip Replacements
Heavy Metals in Blood
Currently, our artificial hip investigation is focused on identifying all patients with past hip replacements who have been diagnosed with elevated cobalt, chromium or titanium levels and/or heavy metal toxicity, a condition often called “metallosis”. Unfortunately, the metallosis disease process may go unnoticed for a long period of time – the patient may experience no symptoms until suffering tissue death and the hip prosthesis begins to fail. Fortunately, detecting metallosis is not difficult. A simple blood test administered by your health care provider can determine whether you have elevated metal ions in your blood stream.
Recent scientific literature strongly associates heavy metal toxicity to many hip systems on the market. Most cases of metallosis appear to come from early wear in hips systems involving both a ball and liner made of metal. These his systems are called Metal-on-Metal (“MOM”) systems. A recent study has revealed failure rates as high as 49% with some MOM hips. This same literature has also identified metallosis occurring in polyethylene or ceramic based hips due to metal debris from the metal junction between the ball and femoral stem called the trunion or tape neck junction. While the reasons for failure are often complex, one of the primary concerns for patients is that elevated metals may lead to tissue death and damage around the artificial hip ultimately causing its failure. Another growing concern is that metallosis may lead to systemic injuries such as: liver and/or kidney damage; eye sight and/or hearing loss; enlargement of the heart; and bladder cancer.
Acetabular systems have gone through significant design changes over the years. One of the main design modifications relates to the chosen materials used in manufacturing the ball and liner which make up the bearing surface interface. Materials used total hip replacement systems (and more recently, resurfacing systems) have historically included polyethylene and ceramics. However, research and development efforts turned to the prospect of coupling a metal ball and metal liner or mono-block principally directed at the goal of increasing device longevity due to known wear rates, measured at 5 and 10 years, relating to poly and ceramic components. However, manufactures are responsive for ensuring that patients are not placed at unreasonable increased health risks. Recently, the metal-on-metal design has come under heightened scrutiny by the scientific community, medical providers, the FDA and consumer attorneys. Fueling this increased scrutiny, a large number of adverse event reports have been received by the FDA from physicians, surgeons and patients relating complications to the metal-on-metal design. Data from European and Australian Registries (which track product performance and measure failure rates) have documented increased failures with the metal design including metallosis processes.
The range of side effects, including:
- early failure
- premature revision surgery.
Unfortunately, unlike the failures which were seen with poly and ceramic component failures, metal on metal bearing wear releases metal ions causing serious and life threatening toxic response to the localized tissues in the hip. At the very least, metallosis starts to kill tissue proximate to the failing hip. This necrotizing of tissue can reach the outer reaches of the hip very quickly and cause damage to both the hip bone (within the acetabulum) and tendons and supporting structures.
In August of 2010, the DePuy ASR hip implant system was recalled after the Joint Registry within the United Kingdom revealed very high failure rates. Sales of the ASR in Europe preceded sales in the United States by 3 to 4 years. Accordingly, this high failure rate provides a dire and ominous forecast for patients in the United States. A systematic review of institutional reports detailing early failures in the ASR in Europe reveals that women are at increased risk for failure within the first several years due to the typically smaller sized hip device. Due to very tight clearance between the ball and mono block of the ASR (80 to 120 micrometers) and shallow clearance of the design, the ASR was destined to failure before its first sales. For men, due to the larger diameter of their components, the mean failure rate for metallosis takes place between years 4 and 7 post implant. Due to this latent period (latency), the product remained on the market in Europe (and the U.S.) longer than it should have.
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If you or someone you love has been diagnosed with metallosis, or heavy metals in the blood due to a metal-on-metal hip replacement, you could be entitled to monetary compensation. Call us toll free at 1 (888) 255-2956, or complete the form below.
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