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.

The Dangers of Revision Surgery

The removal of a Rejuvenate or ABGII is generally considered by orthopedic surgeons to be much more complex than the removal of other hip implants due to the fact that the stem is implanted more deeply into the femoral bone. The removal of the ABGII or Rejuvenate therefore requires the surgeon to “dig out” the implant, leaving less bone behind to attach the new implant to. Because the surgeon must take so much time to get the ABGII or Rejuvenate out of the body, the surgery is typically a lengthy one—from four to five hours. When patients are on the operating table for this length of time, infection, excess bleeding and nerve damage are all possibilities.

Some patients even develop deep vein thrombosis following their revision surgery due to the lengthy recovery time that can last up to six weeks during which the patient must remain relatively inactive. In some cases the bone may grow around and encapsulate the hip joint following a revision surgery therefore some surgeons recommend radiation treatment immediately following the surgical procedure. When the ABGII or Rejuvenate are removed, many patients will experience broken femurs and the dislocation rates are much higher in these revision surgeries. Finally, the mortality rate of revision surgery goes up from 1 percent for the first implant surgery to 2.5 percent for revision surgery according to Drug Watch.

The Emotional Toll of Revision Surgery

Any time a patient must undergo revision surgery they are likely to be anxious and worried about their physical recovery and whether they will be able to return to work. Those patients who must undergo revision surgery because of a defective device which could be wreaking havoc in their body are under additional stress. It can seem that either way they go—whether they agree to a revision surgery or keep their recalled Stryker Rejuvenate and/or ABGII implant and hope for the best—they are putting their health at risk.

The Expected Lifespan of Hip Implants

Hip implants were originally marketed as lasting from ten to fifteen years therefore most surgeons would caution their potential implant patients to wait as long as possible to have the first implant in order to avoid a revision surgery. When the metal-on-metal hip implants hit the market they were believed to last even longer—as much as 20 years. This was extremely good news for all the relatively young patients (in their sixties or seventies) who needed a hip implant as it could be reasonably expected to last as long as the recipient lived. Unfortunately, before these devices made it nearly that long they began causing problems for recipients. The Rejuvenate was granted FDA approval in 2008 while the ABGII received approval in 2009. A short time later the FDA began receiving adverse event reports on both devices.

Patients were experiencing corrosion, infection, inflammation and symptoms of metal toxicity. During the revision surgery for Rejuvenate or ABGII implants the device must be removed, the cement cleared away, bone grafts placed if the femur is defective then a new hip device must be implanted and the incisions sewn shut. Even those patients who have not yet experienced adverse health events from the Stryker ABGII or Rejuvenate are advised to work closely with their physician and have blood levels monitored often. It can be advantageous for those with either of these implant devices to seek qualified legal representation as well. 

stryker modular-neck hip stem