Saunders & Walker P.A. Your Source For Accurate Information
Stryker Rejuvenate / revision comparison
With the recent announcement of a $2.47 billion settlement offer from
Johnson & Johnson over its flawed Articular Surface Replacement (ASR)
hip implant, it is important to remember that the ASR, while the most
popular, was only one of many metal-on-metal hip implants on the market.
The Rejuvenate and ABGII hip replacement systems, both made by Stryker,
were recalled in July 2012. More than 30,000 of the Stryker hip systems
have been installed worldwide, 20,000 of them in U.S. patients. The recall
came after the implant was been found to be prone to corrosion, joint
dislocation, and the release of metal ions, which can cause metallosis,
tissue inflammation, necrosis and death. The announcement has since led to
hundreds of lawsuits being filed against Stryker.
I anticipate that Stryker will eventually have to make a settlement offer,
particularly if the J&J settlement is accepted, and that any offer made would
have to take the ASR settlement into consideration. But it is important to
note here that there are additional factors that come into play regarding the
Stryker hip replacements, and the average award of $250,000 in the ASR
settlement should only provide a baseline, not a comparison.
Most significant is the increased difficulty of doing revisions. The ASR
is a modular system and revisions usually involve only replacing the
cup and ball and don’t require a new stem to be fitted in the patient’s
Stryker was also a modular system but revisions are much more complicated
because of problems with the stems and necks. The stems in these joints
were designed to fuse with a patient’s bone, however, post market data
revealed evidence of corrosion and fretting after the devices were implanted.
Because of this, any revision of Rejuvenate and ABC II will have to involve
replacing the stem. This is a complicated procedure and often extremely
painful. In many cases the revision often requires splitting the patients femur
to remove the stem.
Revision hip replacements are more complicated surgeries and the outcomes
are not as good as the first hip replacement. Even more so when it involves
the stem replacements required for the Stryker systems. Patients receiving
replacement prosthetics often have issues with bone loss and fit. The
promise of a better quality of life is greatly diminished because revised
artificial hips rarely perform as well as the first prosthetic.
The increased difficulty of Stryker revisions would have to be taken into
consideration in any award settlement. I believe that the $250,000 average
award in the ASR settlement would only be used as a starting point in
the Stryker negotiations and that the pain and suffering caused by the
more difficult revisions should be a major consideration and increase any
Some doctors have predicted the failure rate for the Rejuvenate and ABGII
hip replacement systems might go as high as 70 percent. Relief for these
patients can’t come to soon.