Should I Get My Stryker Rejuvenate Removed?

“Should I get my Stryker Rejuvenate removed?” This is the question on the minds of many of those who received a recalled Rejuvenate or ABGII and are now experiencing health issues as a result. It might seem an easy decision for those who have suffered total failure of the Stryker hip implant or who have suffered symptoms of metal toxicity yet it may not be that clear a choice. Revision surgery for the Stryker Rejuvenate or ABGII is both serious and complex. Removal of the hip implant devices includes removing the neck implant piece using a modular neck extractor which is placed under the base of the neck, and, in some cases may need the help of a mallet to completely extract the neck piece. The stem is removed next, using a modular stem extractor which implements a connection pin and locking arm. Stem extraction in these Stryker models is considered risky as the bone can shatter during the extraction.

Recovery Following Stryker Revision Surgery

Recovery time following revision surgery of a Rejuvenate or ABGII can be significantly longer than that of the original implant surgery. Such a long recovery time can impact every aspect of the patient’s life. If the patient is unable to return to work for up to six weeks, jobs could be lost and wages will certainly be forfeited. Medical expenses can mount alarmingly, and the inability to perform day-to-day tasks during recovery can lead to necessary assistance. Those patients who suffered a broken femur during the revision surgery may have to be in a wheelchair for months while the femur heels before revision surgery can be completed.

Why Should I Get My Stryker Rejuvenate Removed?

The reasoning behind having a Stryker Rejuvenate or ABGII removed generally centers around fretting and corrosion which in turn can lead to inflammation, chronic pain and tissue and bone degradation or loss. Once the bone and tissue surrounding the Stryker hip implant begin to deteriorate the Stryker implant may loosen. This loosening can lead to a total failure of the hip implant. Further, symptoms of metal toxicity including hearing and vision loss, disruption of DNA, depression, irritability and anxiety, vertigo, gastrointestinal, cardiovascular, renal and thyroid problems and the development of pseudo-tumors can trigger the decision to replace the all-metal Stryker implant with a ceramic or polyethylene hip device.

Making the Necessary Decisions to Have Your Stryker Rejuvenate Removed

If you and your doctor feel your Stryker hip implant must be removed in order to preserve your mobility and your health, you must collect a certain amount of information. You will need to know the name of the surgeon who performed your initial Stryker hip implant as he or she could be called to testify during a future lawsuit. Contacting the surgeon or the hospital where your initial surgery took place will give you the Stryker model you were implanted with. A second surgical opinion could be helpful during this time so you can be certain you should get your Stryker Rejuvenate removed. After you have made the necessary decisions as far as whether you will have your Stryker implant removed, it may be a positive step for your future to look into your legal options.

Is Dual Modularity the Real Defect of the Stryker Rejuvenate? How the Rejuvenate Recall May Affect Recipients of the Implant

This past July Stryker Orthopedics recalled two hip implant models: the Rejuvenate and the ABGII. The Rejuvenate gained FDA approval only a few short years earlier, in 2008. The approval for the Rejuvenate fell under a process known as the 510(k) which has come under fire after many devices approved under the process were found to be defective. Under this process a new medical device must only show it is substantially equivalent to a device which has already garnered FDA approval. Clinical trials are not a requirement of the 510(k), therefore many people have ended up harmed from a defective medical device approved under this process.

In fact, the Rejuvenate received FDA approval based on its similarity to the Wright Profemur modular neck device. The Pro-femur has not been recalled, however since its introduction to the market in 2000, there have been a significant number of adverse reports regarding the device as well as injury lawsuits filed against the company. Many of these lawsuits allege that Wright was aware of the problems associated with the Pro-femur including an unusually high risk of failure and fracture. Like the Rejuvenate, the Pro-femur also has a significant risk of fretting and corrosion.

Is the Stryker Rejuvenate Defective Because of the Dual Modularity?

Originally all hip implants were designed with one junction between the ball and the neck portion. Dual modularity implemented a junction between the ball and the neck as well as a junction between the neck and the stem. Stryker’s goal with the new dual modularity design was to allow surgeons to use multiple necks with various angles and lengths so a custom fit for each individual patient could be obtained.

The surgeon can choose the size and length of the ball, the length of the stem section, the shape and size of the upper end of the femoral component and the degree of rotation and offset. While in theory the dual modularity hip implant device should provide a huge gain in performance as well as putting an end to safety issues which occurred from a poor fit. But dual modularity design also increases the likelihood of separation between the body and the neck, thus increasing the levels of metal ion debris.

When Dual Modularity Causes Corrosion

There are three types of corrosion the Rejuvenate is subject to: crevice corrosion, fretting corrosion and galvanic corrosion. When a dual modularity device such as the Stryker Rejuvenate is used, a good taper must be implemented at the modularity points. Many hip implant manufacturers use a Morse taper however due to a variety of manufacturers, the tapers are not uniform in their dimensions. Even the slightest variance can greatly increase the risk of dislocation for the patient.

The Morse taper may also connect two disparate materials which can also increase the risks of fretting and corrosion. When a ceramic femoral head is used, the Morse tapers which join the head with the shaft can produce stress within the ceramic material. These are known as hoop stresses and can lead to serious fractures of the ceramic head when products of two different manufacturers are placed together.  As you can see, the dual modularity of the Stryker Rejuvenate could well be reason for the recall.

How are the Stryker ABGII and the Rejuvenate Different?

The Stryker Rejuvenate hip implant device received FDA approval in June of 2008, while the ABGII hip implant device received FDA approval in November, 2009. Just a few short years later the FDA began receiving adverse reports regarding both hip implants. In April, 2012 Stryker issued an Urgent Field Safety Notice to doctors and hospitals stating the risks of fretting and corrosion, leading to metal ion debris. These microscopic cobalt and chromium ions can enter the bloodstream or lodge in nearby hip tissues, creating a host of adverse health issues.

When the shards burrow into the hip tissues, inflammation, chronic pain and the destruction and death of tissue and bone can occur. Should the cobalt and chromium enter the bloodstream, metal toxicity can occur, resulting in cardiovascular, neurological, renal, thyroid and gastrointestinal issues, loss of vision and hearing, the development of pseudo-tumors, DNA disruption, chromosomal abnormalities, chronic headaches, vertigo, depression, anxiety, and irritability.

Following the field safety notification, Stryker issued a recall of both the ABGII and the Rejuvenate in July, 2012. Between the time the devices received FDA approval and the time of the recall, over 20,000 implants were sold; it is believed most of those were implanted into patients. While Stryker claims their failure rate to be somewhere around 12%, independent studies have placed the risk of failure much higher—some as high as 48-50%. This means that while the lawsuits presently number in the low hundreds, it is likely there will be many more filed in the next year.

The Similarities Between the Rejuvenate and the ABGII

The basic design of the ABGI and Rejuvenate vary considerably from the design of other metal-on-metal hip implant devices. The primary differences revolve around the fact that the Rejuvenate and the ABGII implement a ceramic ball rather than a cobalt and chromium ball as many other all-metal devices. In fact, it was widely believed that Stryker’s Rejuvenate and ABGII would not cause the same adverse health risks of the other metal implants due to the ceramic component included in the design.

The design of these two Stryker devices kept a metal neck and stem piece, and offered a wide variety of sizes and lengths of components in order to allow the surgeon to piece together a hip implant which would most closely align with the individual’s body type and level of activity. Unfortunately, the claims of Stryker regarding the Rejuvenate and ABGII did not pan out as expected. The metal joints between metal parts bring a significant risk of fretting and corrosion due to the movement in the joints.  

Differences in the Stryker ABGII and the Rejuvenate

Perhaps the primary difference between the two recalled Stryker hip implants is the hydroxyapatite porous coating; while the coating of the Rejuvenate is very rough and deep, encouraging the bone to grow deeply into the coating, the coating of the ABGII is much shallower and smoother. During revision surgery, the coating of the ABGII makes it considerably easier to remove the device and implant another. Both the ABGII and the Rejuvenate stems are manufactured using a propriety blend of titanium, molybdenum, zirconium and iron. While Stryker claimed this innovative mixture would resist fretting and corrosion, post-market data did not support that claim.

The neck piece of both devices is constructed from cobalt and chromium, however the proportions of the metals are somewhat different. The stem of the Rejuvenate is longer than the stem of the ABGII, again, making the Rejuvenate more difficult to remove during revision surgery as it is implanted more deeply into the femur. If you are the recipient of either a Stryker ABGII or Rejuvenate it is important that you speak with your physician regarding your levels of cobalt and chromium.