It seems sort of nonsensical to blame the victim for his or her condition but that is what medical device maker Stryker appears to be doing in an April Field Safety Notice (FSN).
In the United Kingdom, medical device manufacturers are required to report to the MHRA, their version of our U.S. Food and Drug Administration (FDA), any corrective actions to their products or plants they are undertaking, especially if there is a technical or medical issue that could result in serious injury or death.
In a Field Safety Notice from April, Stryker appears to be blaming the victim when the company says an overweight patient with the wrong blood chemistry or with a prior disease history may be contributing to his own “adverse event” or complications. The Kalamazoo-based manufacturer makes no mention of any possible “defect” in the product design or manufacture that may be to blame for patient injuries.
The medical devices named in the April field action were the stems and necks of the ABGII modular hip system and the Rejuvenate modular hip system.
The company tells surgeons it has updated its Instructions for Use because one percent of reports involve revisions due to corrosion around the modular neck junction which may dump excessive metal debris or ion generation into the blood stream. By way of explanation, Stryker says some patients may have a “heightened sensitivity to these ions” and may have an allergic reaction which also could lead to a revision surgery.
The company does admit that wear and corrosion may occur whenever two surfaces such as the hip head and the modular neck come in contact. However, the instructions warn that patient-specific conditions such as diabetes or infection may affect the rate of corrosion.
Additionally, the contact between body tissues and structure and metal ions may result in inflammation around the tissues and an immunological response due to metallosis, dead tissue or necrosis and/or pain. Sensitive patients may experience pain symptoms associated with infection and swelling at the joint site which could ultimately result in early revision surgery.
The Instructions for Use were updated to include an explanation about a patient’s post-operative pain. Pain is common after surgery, the company says, and can be caused by factors not directly related to the implant such as a prior history of trauma and disease.
In other words, adverse events might not have occurred if the patient maintained their weight, did not have diabetes, an infection, any history of trauma, or a pre-existing condition.
While the medical device mentioned in the April notice is still on the market, the Stryker Trident Hip Replacement Implant series was recalled in January 2008 – the Trident Acetabular PSL and the Trident Hemispherical Cups which are the socket part of a ceramic artificial hip. The problem was an audible noise that resembles squeaking or popping. Besides sounding like the “Tin Man,” patients have reported pain, discomfort, and bone fractures.
The Stryker recall has been overshadowed by the metal-on-metal DePuy ASR hip recall and the Zimmer Hip recall but the Stryker cases are moving forward in New Jersey Superior Court as well as individual states.
The company has also received numerous warning letters from the FDA concerning adulterated devices at its manufacturing plants in Ireland and sanitary conditions at the facility in Mahwah, New Jersey.
Preparing for Trial
We may be getting an early look at the defense strategies Stryker is preparing to try out when it eventually gets to trial. But at some point, Stryker will have to be equally prepared to answer questions asked by numerous product liability law firms such as – How can a hip or component that fails prematurely and permanently injures a patient not be the result of a defective design? Did Stryker adequately warn the patient and his or her doctor about the potential for an early revision or is this evidence of a failure-to-warn? What did Stryker know about its defective product and when did the company know it?