Is Stryker’s Accolade TMZF the Next Metal Hip Implant Failure?
Published by Cal Warriner in Product DefectOver 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.
[youtube]http://www.youtube.com/watch?v=AiLOxyXaIiY&feature=player_embedded[/youtube]
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.
Tags: hip implant, hip implants, hip revision, implant cases, medical device, medical device manufacturers, modular implant, recall, Stryker, Stryker Rejuvenate
December 10th, 2012 at 9:29 am
Lt. total hip replacement on 6/28/2010, I was fine for approx 4 to 6 weeks, when I started having the horrible groin pain that one has prior to surgery. Told my Ortho & he said it was just getting readjusting, as this went on he told me I would simply have to live with it as there was nothing that could be done. By Dec. 2011, I had lymphodema of my entire left leg, which was twice the size of my right leg. An MRI was done and a cyst was found in the left groin that was 7 x 4. I was sent to a gynocologist to makes sure it was not a female problem, then I was sent to a general surgeon for removal of the cyst. In Jan 2012, they aspirated the cyst & got it down to about 2 x 2, which did give me pain relief & less swelling of my leg. The cyst had attached itself to my femoral artery & femoral vein. In March I went back to my original ortho Dr. & he ordered another aspiration for a culture (since one had not been ordered for the first aspiration) but they could not get any fluid out of the cyst, it was solid at that point. I was sent back to my original orthopedic surgeon & he said he did not know what to do, he had never seen this in 60 years practice & sent me to an orthopedic specialist Dr. Kurt Morrison. He ordered another MRI at a higher image but there was to much metal & only picked up metalic glear. He said he coud take out the cyst but since it was attached to the femoral artery & vein, referred me to a vascular surgeon & he removed the cyst on 11/6/12. I was better for the first 2/3 days then the groin & thigh pain came back. I called his office & went in for fluid aspiration & was told that should help, which the pain releif was minimal. He wanted to do a ultra sound the next week & I was told it iwas smaller, therefore getting better. I ask what was causing the excruiciating pain & they siad it was the nerves getting back to where they should be. I was walking with a cain, due to pain I am now using a walker. The pain is constant & I am taking opana, perocet & valium for pain, when I saw my general practice dr., he added neurontin.
I understand that the Accolade hip was put on the recall list in July of this year and I am wondering if I have a case. This hip replacement cost me my job, has been extremely painful for over two years, has taken the quality of my life & I wonder if I have a case.
January 24th, 2013 at 1:02 pm
I was implanted with a Stryker accolade,trydent, on June 1, 2007. I have never had the range of motion that I should have and over the past year i have had coustant groin and hip pain and the hip slipping out of the joint which is extreamely painful.
My orthopedic consultant recommended a hip revision.
January 24th, 2013 at 1:02 pm
I was implanted with a Stryker accolade,trydent, on June 1, 2007. I have never had the range of motion that I should have and over the past year i have had coustant groin and hip pain and the hip slipping out of the joint which is extreamely painful.
My orthopedic consultant recommended a hip revision.
March 5th, 2013 at 6:27 pm
Hello I had hip replacements yes both with stryker products stem accolade yet not sure if it
is the TMZF but it is the accolade stem by stryker! next the cup is the MDM that said would you folks call me to answer a few questions because I;m having issues with the replacements.
Thank you kindly Linda