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This article was originally published in The Gray Sheet

Executive Summary

CDC confirms presence of rare bacterium Clostridium sordellii in Cryolife-processed human donor condyle tissue implanted in a 23-year old Minnesota knee surgery patient who died Nov. 11; the bacterium was not found or implicated in two other Minnesota total knee replacement patient deaths. Cryolife does not intend to alter its processing protocols after CDC, FDA and the Minnesota Department of Health found no connection between the deaths and made no recommendations for changes (1"The Gray Sheet" Dec. 10, 2001, In Brief)...

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Atlanta firm settles lawsuit with the estate of Brian Lykins, a 23-year old Minnesota knee surgery patient who died in November 2001 after receiving CryoLife-processed human condyle tissue infected with Clostridium sordellii (1"The Gray Sheet" Dec. 24, 2001, p. 32). The firm believes that its insurance is "adequate" to cover remaining liability claims...

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CDC issues morbity and mortality report identifying cases of allograft-associated bacterial infection March 14. Of 26 named cases, 14 were identified as using CryoLife-processed tissues. "Some of the infections are likely not due to the tissue," CryoLife President/CEO Steven Anderson maintained during a March 15 teleconference downplaying the report and emphasizing that it is a summary of previously released information. Though a measure of increased oversight by FDA is anticipated, the firm says it is not aware of "serious" infections of the rare bacterium Clostridium sordellii since a 23-year old Minnesota knee surgery patient implanted with Cryolife-processed human donor condyle tissue died Nov. 11, 2001 (1"The Gray Sheet" Dec. 24, 2001, In Brief)...

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