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Victims of Stryker’s Latest Recall Receiving Notice

Defective Medical Devices

Lawsuits have been filed against Stryker since 2013 alleging that its line of TMZF hip replacement stems are a danger when combined with metal femoral heads. However, patients who have received this potentially dangerous combination of products are just now being notified. Oddly enough, Stryker is not the one doing the notifying. Despite recalling approximately 44,000 metal heads in 2016, Stryker has left it up to surgeons to notify patients. Some doctors have now taken it upon themselves to write to their patients explaining their concern over the product’s safety.

To compound the danger, Stryker’s instruction in its recall is for patients to “continue to follow up with their doctor at their normal scheduled appointment.” Most patients are released from the doctor’s care after one year of follow-up. So, if a patient’s implant has been in for a few years, then they are not scheduled for any follow-up appointments.

Dangerous Situation for TMZF Stem Hip Recipients with Metal Heads

This is a very dangerous situation for patients. All patients who received these implants should see their doctor to obtain baseline testing to see if, in fact, their device is already failing despite a lack of symptoms. However, since only a small handful of patients are even being told their implants are subject to a recall, thousands are left in the dark and have no idea they may be in danger.

These devices fail in much the same way tens of thousands of metal implants have failed over the past 10 years. At the connection between the TMZF titanium stem and the chrome/cobalt metal head motion leads to corrosion. This, in turn, leads to material loss. The process leads to toxic metal debris getting into the patient’s tissue and bloodstream. The metal debris can result in the death of both muscle and bone, as well as an inflammatory response leading to large fluid collections. Not all patients who suffer from this problem feel symptoms. Left untreated, the process can cause muscle and bone loss substantial enough to leave the patient with serious disabilities even after the bad device is removed and replaced.

Letter Sent from Local Surgeon

LFIT V40 recall

Read the letter here. Click on the image.

The latest letter that has come to my attention is from a surgeon at Holy Cross Hospital in Fort Lauderdale, Florida. The letter was sent to one of my existing clients who has already undergone revision surgery because of the above problems. He forwarded the letter to me.

Potentially thousands of these devices were implanted in Florida because of its large retirement population. Any patient implanted with a Stryker hip after 2006 should contact their surgeon and ask for their specific implant model. If the patient has any combination of a TMZF stem (Accolade, Meridian or Citation) and a metal head, they should insist on having a baseline blood chromium and cobalt study even if they are not having problems. Obviously, if the patient is having problems, he or she should consult with their surgeon as soon as possible. Finally, if the blood study shows elevated cobalt or chromium in their blood, they should insist on having a MARS protocol MRI scan of the affected hip.

One last comment about the recall. Stryker is only recalling a small subset of the metal heads it manufactured from 2002 – 2011. I have personally seen numerous failures in patients who received metal heads that are not on the recall list either because of their size or because they were manufactured after 2011. If it were me, I would not be satisfied if my surgeon told me I had nothing to worry about just because the metal head I have is not on the recall list.

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