Is Stryker’s Accolade TMZF the Next Metal Hip Implant Failure?Published by Cal Warriner in Product Defect
Over the past few months (and well before the recall), our law firm has been investigating Stryker Rejuvenate and ABG II failed hip implant cases on behalf of patients from Florida, Arizona, Ohio, Minnesota, Illinois, and other parts of the country where these Stryker devices were heavily marketed. As a byproduct of our Stryker Rejuvenate investigations, we have noticed a number of patients who have experienced serious adverse effects associated with their implants (such as metallosis, elevated cobalt levels, corrosion of the device at the junction of the modular pieces, pseudotumor formation, presence of milky inflammatory fluid around the implant, etc.) and the failure of their respective hip implants is strikingly similar to the device failures experienced by patients implanted with Rejuvenate hip implants. However, these patients have been implanted with a different product manufactured by Stryker – Accolade TMZF implants.
The Stryker Accolade TMZF implant is a one-piece implant made of a titanium alloy. The alloy is advertised by Stryker as a proprietary blend of titanium, iron, molybdenum, and zirconium developed by Howmedica Osteonics. According to Stryker’s website, this combination of metals is supposed to have superior strength, flexibility and notch resistance when compared to other alloys used in hip implants manufactured by Stryker’s competitors.
As we have discussed in several items relating to other defective and recalled hip implants (including DePuy’s ASR and Pinnacle metal-on-metal devices and Stryker’s recalled Rejuvenate and ABG II hip revision devices), this appears to be yet another example of a failed “better” mousetrap.
True innovation in medical technology can be very beneficial for patients in need of more effective treatment options. Our world and lives are improved daily by these medical miracles. However, it seems that, of late, orthopedic device manufacturers are innovating for innovation’s sake, with only the device manufacturers benefitting. These “innovations” and breakthroughs are seemingly motivated by the need for device manufacturers to have something new and improved to promote, but many have led to so much avoidable pain and suffering for patients.
We already know that the Stryker Rejuvenate hip implant was an innovation that no one needed. Now, we have concerns that the Accolade TMZF may be headed down a similar path. With the convenience and variety afforded by modular devices comes the evil associated with mating metal devices and implanting them in the body. For over twenty years, scientists and surgeons have been writing about failed taper neck junctions with both similar and dissimilar metals. The taper neck junction is where either the neck is inserted into the stem or the ball is attached to the neck. Twenty years ago, scientists were warning about the risks associated with such devices and discouraging their use, only to have medical device manufacturers hoist them upon surgeons and consumers as being the latest and greatest technology.
We have received inquiries from all over the country as well as overseas regarding Accolade hip implant failures. They are failing in the exact same way as the Rejuvenate and ABG II hip implants, with the distinction being that the Accolade corrosion and galvanization appears at a different location. To date, it appears the Rejuvenate is failing at the junction between the neck and stem. The Accolade, however, appears to be failing at the junction between the stem and ball. The failure seems to be very similar to failures described twenty years ago in the literature talking about the inherent problems with use of modular implants, with erosion of the metals occurring once the implant is placed in the body which, in turn, causes metal ions to be cast off into the local area around the device and eventually dispersed throughout the body.
The picture included here depicts an actual Accolade explant. All of the black areas are the result of metal breakdown which occurred after the device was implanted. The patient from whom this implant was removed suffered from metal toxicity, and a hip arthroplasty revision surgery had to be performed within 18 months of the original implantation surgery. Apparently, as is obvious from the photographs, the titanium alloy in the TMZF didn’t agree with the chrome cobalt head.
School is still out on whether we are seeing isolated failures or whether our firm has uncovered the tip of another iceberg, as we did with the Rejuvenate implants a few months ago.