In March 2018, The Morning Call reported that a Pennsylvania lawsuit was filed against medical device manufacturer B. Braun for deliberately concealing defects in its ceramic-coated Aesculap Knee Implant System. According to the plaintiffs’ complaints the device’s ceramic joints do not properly adhere to the cement used to bond the joints to the patients’ bones. This has resulted in a loosening of the Aesculap device which in turn has caused patients to endure pain and difficulty when walking.
Aesculap marketed their “advanced surface” knee replacement system as a better alternative that would eliminate the emission of harmful metal ions in the human body. However, their ceramic coating causes moisture to build up on the implant’s surface below the bone cement and the implant become loose and unstable.
The lawsuit also alleges that Aesculap was aware of this defect and even received a patent on their method of adding more coating to the implants in Germany in 2015 but did not implement this change.
This is yet another example of a defective medical device gaining FDA approval under the 510(k) process, which clears a device for sale without clinical testing on humans if the manufacturer substantiates that it is similar to another device already on the market.
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Medical Device Watch is sponsored by Keefe Law Firm. The medical device approval process in the U.S. allows for the sale of some devices that have not been tested in clinical trials on humans. Our goal is to help people protect themselves from the physical, emotional and financial harm that can be caused by medical devices that are defective.LEARN MORE