Metal and metal hip implants made from titanium, molybdenum, cobalt and chromium alloy have been all the rage over the past 16 years. There was a rush to the market as each major hip manufacturer made similar products with minor changes and touted that their product was superior to others in the market place.
These companies were aided and abetted by the lax regulatory oversight by the FDA, with the infamous and controversial 510(k) loophole that the agency created.
Under the 510(k) regulatory scheme, all a medical device manufacturer had to demonstrate to the regulators in order to be approved for sale was that their product was substanstially similar to other existing products. No safety data had to be provided.
The orthopedic companies took full advance of this loophole and dumped hip implants into the market and encouraged surgeons and hospitals to use their products.
The graying of America and coverage by third party payors has led to an explosion of the hip implant business. And that is what it is, a huge multi-billion dollar business, which is great for doctors, their free standing operating rooms, hospitals and finally the orthopedic manufacturing companies. You have heard of the Military Industrial Complex, we now have the Medical Industry Complex equivalent for health care.
Now the chickens have come home to roost. It turns out that the metal alloy is highly unstable and prone to corrosion and metal poisoning, leading to painful revision surgery. Case in point, the Stryker LFIT V40 femoral head failures.
Stryker LFIT V40 Femoral Head Fiasco
Over the past several months the honchos at Stryker have been quietly sending out letters to orthopedic doctors, warning them about a high rate of failures and problems with Stryker LFit V40 femoral head hip implant components.
Stryker sent out an urgent field action notice, in which doctors and hospitals were told to quarantine and return certain LFit Anatomic CoCr V40 Femoral Head components manufactured prior to 2011.
The letter warns about a risk of “potential hazards” associated with a failure at the point where the femoral head connects to the femoral neck, which can cause patients extreme pain, walking difficulties and results in urgent or emergent hip revision surgery.
Health Canada Stryker LFIT V40 Femoral Head Recall
In August, Canadian health officials announced an official recall of the Stryker LFit CoCr V40 femoral head medical device. The FDA is missing action and there has been no official recall announcement issued in the United States.
According to Health Canada (their equivalent to our FDA) “Stryker has received higher than expected complaints of taper lock failure for specific lots of certain sizes of LFIT Anatomic COCR V40TM Femoral Heads manufactured prior to 2011.”
Recently, Australian health officials announced and amplified Stryker’s warning to doctors and patients, urging doctors to follow up with patients who had been implanted with the affected component.
And to my knowledge, the Stryker’s warning letter has not been sent to affected patients who have the LFIT V40 component as part of their Stryker hip replacement.
Strker LFIT V40 Hip Failure Lawsuits on the Horizon
Many injured patients who feel victimized by Stryker, are now considering potential Stryker LFIT V40 hip lawsuits, as well as Stryker Accolade hip lawsuits, as the femoral head component was frequently used with the Accolade hip stem.
Stryker is exposed for designing and selling an unreasonably dangerous and defective medical device, and failing to issue a worldwide recall as soon as it became apparent that these devices fail at an alarming rate. I suspect after a few thousand lawsuits the company will offer a settlement package, which unfortunately will be too little too late.
And this is not the first time at the rodeo for defective Stryker hip implants. Back in 2012 the company issued a worldwide recall over its flagship line of ABG II and Rejuvenate line of metal hip implants. After fighting lawsuits for several years, the company capitulated and announced a $1.4 billion settlement.
Shezad Malik is an Internal Medicine and Cardiology specialist, a Texas Medical Doctor (retired) and Defective Medical Device and Dangerous Drug Attorney. Dr. Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.