Articles Tagged with explanted components

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It’s a great question. And I’m glad I asked it for you. Now let me answer it. There are several ways to identify the specific medical device implanted in your body. (A medical device is any manufactured device–like an artificial hip–implanted in the body for the purpose of resolving an injury, curing disease, or improving a person’s health. Medical devices can be artificial joints like hips and knees and shoulders, heart stents and pacemakers, IVC filters, hernia mesh, and hundreds of other examples.)  Some ways of identifying exact product components are better than others. Identifying the medical device several different ways is the best of all.

Product Stickers: The Gold Standard

Product Stickers
It all sort of starts with “product stickers.” These are the identifying stickers that are attached to the box containing the medical device, and they can be peeled off and affixed to a nurse’s hospital note or to another page in the hospital or surgeon’s record for the implant surgery. It goes something like this: the representative for the device maker shows up with the artificial hip components (or other medical device). The surgical nurse or the surgeon will double check that the components are the precise ones needed for the surgery, scan them into the system and note them in the record. The nurse will then peel off the product stickers and attach them to the hospital record and include them with all the other pages of documents explaining details of the surgery. The image at right is an approximation of what the stickers will look like: a bar code, the name of the manufacturer, the specific product name, the Lot and Reference numbers, and other identifying information.

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Artificial hip removed as part of revision surgery

If you have been the victim of a failed medical device like a metal-on-metal artificial hip, you may not ever think about preserving evidence. But it is essential to your product liability case. In this post I want to give you some tips about preserving medical device components that have been removed (“explanted”) from your body in a revision surgery. This information is important for all those undergoing revision surgery, but especially those of you who hope to pursue a product liability case without a lawyer.

Here is a quick illustration: You undergo hip replacement surgery in October 2009. In August 2010, you receive a letter from the manufacturer of the artificial hip stating that a recall has been issued on the medical device implanted in your body. Since the device is implanted in your body, you can’t easily turn it back in for a refund. So you monitor the situation. Ten months later, you begin to feel discomfort, and then outright pain. After a few more months you and your orthopedic surgeon decide to have the device removed in a revision surgery. In this operation, the surgeon will remove the defective parts of the artificial hip and replace them with new, non-defective parts. Those removed parts will sit on a surgical tray, and after the surgery they will end up . . . somewhere. They could be thrown out; they could be placed in a Ziploc bag and abandoned in a storage room; they could be handed over to the medical device manufacturer’s representative, who is often in the room during your surgery.

But they need to go to you.

Quite simply, before the revision surgery, the patient should take steps to ensure that he or she will be given the explanted medical device components. This usually involves careful conversations with the surgeon and the surgeon’s nurse or other staff. Unfortunately, most patients have no idea that need to take this step.

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