Knee Replacement Products-Aren’t They All Tested Rigorously?

Here is a question you might want to put on your list to ask potential knee replacement surgeons.

Are you using any devices that have been fast-tracked through the approval process via a 510(k) clearance by the FDA?

According to the website lawyerandsettlements.com, “a 510(k) clearance is an approval shortcut maintained by the US Food and Drug Administration and allowable when a device is found to be substantially similar to a previous device and can be marketed safely.”  (my italics)

Consider the following story:

In January, 2013, 18 months after being approved, Stryker’s ShapeMatch Cutting Guide was formally recalled by the FDA with a Class I recall.

Get more information at the FDA recall page…

This type of recall is the most serious of recalls responses that can be issued by the FDA. It is reserved for a situations in which there is a reasonable probability that the use of or exposure to the product will cause a serious adverse heath consequences or death.

Stryker’s ShapeMatch Cutting Guides were designed to be customized for each patient based on the surgeon’s pre-surgery planning parameters.

Instead, it was found that the cutting guides were not manufactured to the surgeons parameters perhaps due to a software glitch, which resulted in  mis-alignment of the implants.

As quoted from the the FDA:

The parameters of the manufactured cutting guides may not meet the surgeon’s pre-operative planning parameters entered via the web application. Additionally, Stryker Orthopaedics determined that another software defect resulted in the displayed parameters (e.g. depth of resection, angle of cut) not matching the cutting guides produced. This may result in serious adverse health consequences including joint instability, fracture,need for revision surgery and chronic pain and limitations of mobility.

According to lawyersandsettlements.com,

Hip and knee replacement failures have been on the upswing since new products, many touting new materials and designs, were introduced to the market by way of FDA 510(k) clearance, but have failed up to live up to performance expectations.

Supporting evidence for that statement was not presented with that article but it bears looking into especially if you are a potential knee replacement consumer.

See the full article here…