Since the inception of the metal-on-metal (MoM) hip implant litigation – starting with the DePuy ASR recall in 2009 – the scientific and legal community has struggled to definitively understand the full effects of metallosis. Some corporations even deny the existence of a standard definition of metallosis, while others have paid billions to those adversely affected by these devices and the deleterious effects of metallosis.
The risk of corrosion and metallic debris has been a known potential risk for some time. Because of the immediate effects of tissue damage, pain and elevated chromium and cobalt levels in the blood, there is a need for a revision surgery to remove the MoM and exchange it with ceramic and polyethylene components. Unfortunately, the rate at which certain devices are depositing metallic debris and failing is exponentially higher than doctors thought would happen. Consumers were never warned. The ultimate question now is, what is the ultimate potential effect the exposure of excessive chromium and cobalt levels in the body can have?
In the case report, “Cardiac cobaltism: a rare complication after bilateral metal-on-metal total hip arthroplasty,” published in October 2015 by Dr. J.R. Martin, et al., we see one of the first documented cases of metal-on-metal hip cobalt cardiac toxicity. The subject patient in this study was implanted at the age of 64 in 2008 with a DePuy metal-on-metal hip device in her right hip and another less than a year later in her left hip. At her two-year post-operative appointment, blood testing showed her cobalt levels were markedly elevated at 192 parts per billion, with a normal reading being less than one.
The patient was to undergo a revision surgery to address her complaints of pain and the elevated metal ion levels. She began to develop impaired renal function and shortness of breath. An echocardiogram showed severely abnormal ventricular function. She underwent a cardiac MRI, which showed an “unusual delayed enhancement pattern and hyperenhancement of the atria” as well as a cardiac biopsy to rule out cobalt (Co) cardiotoxicity.
The woman underwent bilateral hip revisions exchanging the metal articulation to ceramic on polyethylene. Extensive evidence of metallosis was found intraoperatively. She was put on anticoagulation therapy to prevent clot formation. Renal function continued to decrease, requiring hemofiltration. The patient then suffered from a “transient episode of acute onset hemiparesis and aphasia” after an intracranial bleed was ruled out she was reintubated seven days post op, day 22 of hospitalization, and she suffered a “hemorrhagic conversion of the previous embolic cerebrovascular event.” She was placed on palliative care and died the next day.
The effects of Co toxicity are “well documented in the literature and can cause cardiomyopathy, hypothyroidism, polycythemia, and neuropathy complications.” Though there is no uniform standard of treating Co toxicity, there are theories which ultimately speed the expulsion of the ions from the body. In the instant study, the patient’s pathology showed she had cardiomyopathy secondary to Co toxicity. The cardiac biopsy showed her Co level to be 25 times higher than the normal limit. The pathologists in this case confirmed that cobalt toxicity more than likely contributed to the patient’s death, secondary to cardiac cobaltism.
This case is one of the first to link mortality with cobalt toxicity due to metal on metal total hip devices. Though this case is still considered rare, it outlines a known potential risk and affirms the standard protocol of testing the blood for chromium and cobalt levels with additional work-up as necessary, including biopsy and the replacement of the cobalt chromium femoral head with one made of ceramic. Many orthopaedic surgeons around the country have abandoned using metal-on-metal hip systems in favor of ceramic and polyethylene because of concerns about the as yet not fully understood effects of metallosis.
If you need more information about the study or the hip litigation generally, contact Navan Ward, a lawyer in our firm’s Mass Torts Section. Navan is the lead lawyer handling hip litigation for the firm. He can be reached at 800-898-2034 or by email at Navan.Ward@beasleyallen.com.
Source: J.R. Martin, et al., Cardiac cobaltism: a rare complication after bilateral metal-on-metal total hip arthroplasty, Arthroplasty Today (2015), http://dx.doi.org/10.1016/j.artd.2015.10.002
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