Why Diagnosing Problems in Stryker Rejuvenate Hip Implants is So Difficult

When the Stryker Rejuvenate and ABGII were recalled in July of 2012, citing potential risk of fretting and corrosion at the neck juncture, many of the implants had already been removed during revision surgeries. Unfortunately, since most physicians were unaware of the problems with the implants, the operative reports were unlikely to list this corrosion. In other words, since the doctors hadn’t been told what issues to look for, there were few records stating that corrosion was a factor in the revision surgery. When Stryker originally told hospitals and surgeons (in an Urgent Field Safety Report in April of 2012) that there could be corrosion or fretting and release of metal ions, there was still no mention of that corrosion occurring anywhere except at the neck juncture.

Sales Dip for Stryker Following Hip Implant Recalls

Stryker sales have shown a definite dip in the quart since the recall of the Stryker Rejuvenate and ABGII hip implants in July. The hip implant recall came just months after Stryker issued an Urgent Field Safety Notice to hospitals and physicians in April of 2012 citing the potential of fretting and corrosion at the neck juncture as well as the risk of metal ion release. Stryker’s hip implant sales dropped nearly 10 percent while its knee implant sales dropped 4.3 percent.

Why the Dip in Revenues?

A Stryker company official stated the recalls of the Rejuvenate and ABGII had only a “modest impact” on the company’s third quarter drop in sales. While the recalls certainly would have impacted Stryker’s revenues, the overall economy may also have played a part. Joint replacement surgical procedures are considered elective most of the time. Those with insurance may delay the surgery to avoid missing work while those without insurance likely cannot afford the procedure. Stryker’s CFO, Curt Hartman also stepped down after two decades at the helm. He reportedly received a 1.5 million dollar separation package although he will remain as an adviser to Stryker through February, 2013.

New Design an Improvement Over Metal-on-Metal Implants?

Metal-on-metal hip implants have been responsible for scores of side effects among recipients. The Rejuvenate garnered FDA approval in 2008 and the ABGII in 2009 and were believed to be not only safer than the all-metal implants but the design was innovative in that the stem and neck were separate parts and were manufactured in a variety of sizes. The surgeon could choose the best size according to the size and activity level of the patient. Because the ball of the Stryker models was ceramic and plastic lined the acetabular cup, it was assumed there would be no metal-on-metal parts rubbing against one another, resulting in metal ions shearing away into the body.

Risk of Metal Ion Release

Unfortunately, the neck portion of the Stryker Rejuvenate is made of cobalt and chromium and even though the ball is ceramic, there is a metal intersection as well as metal trundles at both ends of the neck portion. Body fluids trapped in the trundles can lead to corrosion and the metal intersections can also corrode, sending metal ions into the surrounding tissues or the bloodstream. Although the levels of metal ions in the bloodstream from the Rejuvenate may not reach the level of the all-metal implants, any metal in the body can cause issues for the patient. Those patients who are extremely active have an even greater risk of metallosis, leading to pain, necrosis, infection and failure of the implant. While Stryker’s sales may have taken a dip, it is likely that they will soon have bigger problems as eight lawsuits have already been filed following the Rejuvenate and ABGII hip implant recalls. 

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Consolidation of Stryker Rejuvenate Hip Lawsuits Placed in New Jersey

The state of New Jersey is expected to consolidate at least ten StrykerRejuvenate and ABGII hip implant lawsuits before one judge in order to expedite the handling of these cases. Multi-district and multi-county litigation is described by Class Action Litigation website as a procedure utilized by federal and state courts to transfer all pending cases which are very similar in nature before one judge. This procedure allows lawsuits to move in a more expeditious manner through the discovery phase while still allowing the injured party to seek an individual trial and have their settlement adjusted based on the degree of injury. This is unlike class action lawsuits which dictate that all members share equally in the settlement even though it is unlikely that all injuries would be equal. The first ten cases are coming from Florida, Minnesota, New Jersey and Arizona. Hackensack, NJ was chosen as the consolidation point because it is close to Stryker headquarters. 

Why Patients Aren’t Getting the Message Regarding the Stryker Rejuvenate and ABGII Recall

Despite a Stryker Orthopedics recall in July of 2012 for the company’s Rejuvenate and ABGII hip implant devices, recipients of the devices are simply not getting the information they need about potential implant hazards. Canada, who appears to be a bit ahead of the curve when removing potentially dangerous medical devices and drugs from the market, experienced a recall of the implants almost two months earlier. An Urgent Safety alert was sent out by Stryker to physicians and hospitals in April of 2012, advising that there could be potential problems with the hip implants.

This Safety Alert stated that the potential hazards of the Rejuvenate and ABGII include: “Excessive metal debris and/or ion generation. Fretting and/or corrosion at or about the modular neck junction may lead to increased metal ion generation in the surrounding joint space.” Even though Stryker is aware of the potential safety risks of these two hip implants and issued a voluntary recall, they have yet to create a specific program which will both identify those with a Rejuvenate and ABGII as well as aid hip implant recipients in getting the help they need.

Should Stryker Follow DePuy’s Lead for Their Recalled Hip Implants? 

Although Johnson & Johnson announced a method which would allow DePuy ASR victims to get assistance shortly after the recall was issued, Stryker has yet to follow up with similar help for their implant recipients. Johnson & Johnson and its subsidiary, DePuy, hired a third party – Broadspire Services, Inc. - to administer patient claims associated with the ASR recall. Broadspire generally manages workers compensation and other medical claims on behalf of insurance companies and employers, so many were surprised that DePuy and Johnson & Johnson had chosen this route.

Nonetheless, recipients of the ASR felt like DePuy was at least doing something to help them get the treatment they needed while recipients of the Rejuvenate and ABGII have received nothing at this point. The process of physician notification can be laborious and slow which means that a fair number of the estimated 30,000 – 50,000 recipients of the Rejuvenate and ABGII have yet to receive notification of the potential risks of their hip implant.

Dangerous Potential Complications When Recipients of the Stryker Rejuvenate and ABGII Undergo Revision Surgery

Following the recall of the Stryker Rejuvenate and ABGII hip implants in July of this year, physicians are still attempting to notify all those who received one of these implants about the potential hazards. Stryker Orthopedics sent out an Urgent Safety Notice to hospitals and physicians regarding these two hip implants in April prior to the recall in July. Canada recalled the two hip implant devices in May, soon after the safety notice went out. It is fairly likely that many of those recipients of the Rejuvenate or ABGII are as yet unaware of the recall due to the process involved in notifying all patients.

Potential Hazards of the Rejuvenate and ABGII

Marketing data states that there are between 30,000 and 50,000 recipients of the Stryker Rejuvenate and ABGII hip implants across the globe. In their safety letter Stryker noted that the potential hazards of these implants included fretting, corrosion and “excessive metal debris and/or ion generation.”  In fact, many Rejuvenate and ABGII patients began experiencing adverse health effects soon after their implant surgery. Some of the more common negative health effects include inflammation, hip or groin pain, popping or creaking noises, failure of the hip due to tissue damage or metal toxicity which comes with its own set of negative health symptoms. Other recipients of the Rejuvenate or ABGII experienced no negative symptoms for a year, two years, or even more and some patients have yet to experience adverse health effects.

The Likelihood of Negative Health Effects

Unfortunately, statistically speaking, a fair number of those who have not yet had negative health effects may see those effects in the future.  In other words, the likelihood that the hip will fail, inflammation or pain will set in or metal toxicity will occur is much greater than originally believed. This is seriously bad news for all the patients who put their trust in a product that was supposed to be safe for implantation into their body. When metal hips fail or there are symptoms of metal toxicity, revision surgery could be the only option. As many as 50,000 people in the U.S. alone will be required to go through revision surgery due to a failed hip implant.

Stryker Rejuvenate and Stryker ABGII Hip Implant Revision Surgery: Few Good Choices Available

The July, 2012 recall of the Stryker Rejuvenate and ABGII hip implant devices followed an Urgent Safety Alert which Stryker Orthopedics issued in April, 2012. The alert went out to physicians and hospitals which then had the burden of notifying all the recipients of the implants. Because there are between 30,000 and 50,000 worldwide recipients of the Rejuvenate and ABGII, the process of notifying each implant patient may end up being very slow and laborious. This means that there could be thousands of implant recipients who are unaware that their hip implant has been recalled.

The Potential Risks of the Stryker Implants

Stryker’s safety alert admitted that these particular two metal implants could have certain potential risks. These risks primarily include fretting and corrosion as well as metal toxicity when the cobalt and chromium parts of the implant rub against one another during periods of activity, shearing off tiny metal ions. These microscopic shards can become lodged in the surrounding tissue causing pain, inflammation, tissue damage and total failure of the implant. The ions can also travel to the bloodstream causing many adverse health issues including cardiovascular, neurological, renal and thyroid problems as well as DNA disruption.