We have been investigating Stryker trunnion failure cases since 2012. During our involvement in Stryker Rejuvenate and ABG II stem failures and subsequent recall we began receiving inquiries into Stryker monoblock stem trunnion failures. At first glance it appeared that most of these failures were associated with Stryker TMZF stems (Accolade, Meridian and Citation). This made sense to us since the Rejuvenate and ABG II were also TMZF titanium alloy stems. We filed the first Accolade failure case in 2013. We’ve filed over 100 such cases since.
The monoblock TMZF stem failures looked exactly like the Rejuvenate and ABG II failures. Patients suffered from high levels of cobalt and chromium in their blood, the development of large fluid collections and pseudotumors and frequently pain, disability, bone and tissue destruction. Upon deeper investigation it became clear that corrosion, fretting and the release of metal wear debris was occurring at the connection between the stems and metal femoral heads. This was exactly the same failure mode as the dual modular Rejuvenate and ABG II just at a different metal on metal connection. The problem is frequently referred to as “metallosis.”
Stryker Trunnion Failure – Redesign?
In 2011, with little or no explanation, Stryker “redesigned” its best-selling Accolade stem. The changes were very subtle but, the most glaring change was barely mentioned. Stryker eliminated TMZF titanium and instead replaced it with Ti6 titanium. No coincidence there yet a change that was seriously downplayed by Stryker and thus, completely lost on the orthopedic community. The timing is eerily similar to the recall of the TMZF Rejuvenate and ABG II stems.
So, for years patients with painful hips returned to their surgeons only to be told that their x-rays looked fine and their implant was not on the recall list. Patients were sent to more rehab, injected with steroids and some referred to their back doctors to see if it was their backs causing the problem. One of my clients was told it was all in their head and referred to a mental health professional! At the same time Rejuvenate and ABG II patients were being quickly and appropriately worked up and their recalled devices removed and replaced.
Another Massive Stryker Recall
Now, news of the recall is starting to filter out into the orthopedic surgical community. In addition, medical literature is starting to raise awareness of the problem. So, instead of scratching their heads, orthopedic surgeons are starting to do the right testing and voila, they are getting answers. Patients are now getting appropriate care as opposed to receiving the run around. Some doctors, sick over yet another recall (some have implanted hundreds of these devices as well as hundreds of Rejuvenate and ABG II’s) are reaching out to their patients and asking them to return for appropriate follow up. I personally know of surgeons in Pennsylvania, Wisconsin, Georgia, Texas and Florida who have done so.
Stryker Trunnion Failure Cases – Ticking Time Bombs Across the Country
In fact, numerous doctors have published reports of catastrophic failure of Stryker stems when combined with metal heads. In those cases, wear at the connection between stem and head is so severe that the head moves until it grinds the stem to a point and eventually the head falls off of the stem. This means every person implanted with a TMZF Stryker stem and metal head is a, “potential ticking time bomb” as one surgeon has put it.
Thank goodness this information is starting to motivate well-intentioned surgeons to reach out to unknowing patients, many of whom have been living with painful hips for years. In this instance more information is a good thing. Had it come out earlier a lot of pain and suffering could have been avoided.