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There are many recalls and lawsuits that are a result of biomaterials working im

ID: 96828 • Letter: T

Question

There are many recalls and lawsuits that are a result of biomaterials working improperly. Find a medical device that has been recalled or has been the target of a lawsuit because of a failure of the biomaterial (i.e. a pacemaker that doesn't correctly excite the heart would not be a good example). Write a short essay explain how the device was supposed to work, the impact of the failure and how the failure relates to one (or more) of the issues outlined in the biomaterial lectures. Include one or more figures that help support your explanation of the sub questions listed above. Repeat for a device that fail for a different material issue than that of the previous answer. Repeat for a device that fail for a different material issue than that of the previous answers.

Explanation / Answer

1) DePuy ASR metal-on-metal hip implants: This implant was recalled by DePuy orthopaedics Inc. in 2010 by Johnson and johnson after its first launch in 2005. The implants entered the market without going throu pre clinical trials and hence were assessed for their safety before market launch. These were meant to be used in the case of total hip replacement. The reason for the recall was more than acceptable failure rate- about 12% of all patients receiving these implants required revision surgery. Even after the removal of the failed implant from the body it continued to lay harm to the body since the implant deteriorated in the body disposing of high cobalt/cadmium metals in the body. Both these metals are highly toxic to the body leading to nerve damage, infecttion, pain, inflammation, muscle damage and necrosis.The first lawsuit was filed in a U.S in 2010 followed by a second one in Australia (2011)

A few other examples are:

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