Monday, September 2, 2013

Recalled Stryker Rejuvenate and Stryker ABGII: What’s the Difference?

Both the Stryker Rejuvenate and Stryker ABGII hip Stryker implant devices were recalled on July 6, 2012 after demonstrating an increased likelihood of fretting and corrosion which can lead tiny metal ions to flake away from the device, ending up in the surrounding hip tissue or the bloodstream. Symptoms such as pain, inflammation, limited mobility, hip joint failure, the development of pseudo-tumors, changes in DNA and chromosomes, bone and tissue necrosis, and damage to the cardiovascular, neurological, renal, thyroid and gastrointestinal systems as well as a decrease in vision and hearing can result from these cobalt and chromium ions.

 

How the Rejuvenate and ABGII are Alike

Both the Rejuvenate and the ABGII are functionally dissimilar from other hip replacement devices in that both devices implement a ceramic component as an alternative to the “true” metal-on-metal devices. Both Stryker models were marketed to younger patients due to their ability to be custom-fitted by the surgeon, ostensibly resulting in a longer-lasting hip replacement which afforded patients superior range of motion. Although the Rejuvenate and ABGII hip implant devices do not have the metal-on-metal ball and socket design like the DePuy ASR, the design includes a metal neck piece. The metal neck piece can rub against the metal stem, releasing cobalt and chromium debris into the body. So, while the ABGII and Rejuvenate offer a dual modularity design which allows surgeons to choose different lengths and angles for the best fit, each metal joint between two different metal parts brings a risk of fretting from the movement in the metal joints and subsequent corrosion.

 

The Differences between the ABGII and the Rejuvenate

While there are many similarities between the ABGII and the Rejuvenate, there are significant differences as well. Both models implement a stem manufactured from Stryker’s proprietary titanium alloy blend that mixes titanium, molybdenum, zirconium and iron. Stryker claimed this patented blend would resist fretting and corrosion however post-market data revealed otherwise. The neck pieces of the Rejuvenate and ABGII are both constructed of cobalt and chromium however the proportions are different between the two models.  The Rejuvenate implements a longer stem, while the ABGII is shorter. This distinction can have serious implications during a revision surgery. The stem of the Rejuvenate may be inserted more deeply into the femur during the original implant surgery making it much more difficult to remove while the stem of the ABGII is shorter and therefore more easily removed.

 

Perhaps the most important difference between the Rejuvenate and the ABGII relates to the hydroxyapatite porous coating. The Rejuvenate implements a very rough, deep HA ingrowth coating which means that when the bone grows into the coating, it grows in deeply and solidly. The ABGII’s coating, on the other hand, is smoother and shallower which makes it easier to remove from the surface of the bone during a revision surgery. With over 20,000 combined Rejuvenate and ABGII implants sold in the United States, it is possible we will begin seeing an increase in the amount of lawsuits during the coming year. Over 160 lawsuits have already been filed, and at least one multi-district consolidation has occurred. With this multitude of litigation on the horizon, it is important that you find out from your surgeon which type of recalled Stryker model you received in order to evaluate your future legal options.

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