Custom-device regulations at a crossroads

By Jeanie Kennedy

Are they working for you and your patients?

Your patient has already had a total elbow replacement revision. She has a well-fixed revision humeral component but a loose ulnar component. The bone quality of the ulna is compromised so it appears that fixation is unlikely. Instead, the revision component will be fixed to the radius. You’ve contacted the manufacturing representative to inquire about a second custom device, but your request was denied. Every other manufacturer you’ve approached has also given you the same answer: “Sorry, we can’t.”

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