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Biotech / Medical : Biomet BMET on Nasdaq

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To: Cush who started this subject11/21/2001 4:41:45 PM
From: Elmer Flugum  Read Replies (1) of 62
 
Any repercussions?

November 21, 2001

3 Knee Patients Die, Apparently of Rare Germ

By SANDRA BLAKESLEE

Minnesota health officials are struggling to solve a local medical mystery: How did a rare bacterium usually found in soil and fecal matter manage to kill as many as three
healthy men who underwent routine knee surgery in the last two weeks?

The bacterium, Clostridium sordellii, is a "bad actor" that rarely turns up in hospitals, said Dr. Harry Hull, Minnesota's chief epidemiologist. Preliminary laboratory tests
identified it in the blood of one of the patients, a 23-year-old man who had had cartilage grafted onto his knee.

Because the two other patients died similarly — developing severe abdominal pain, a sudden drop in blood pressure and septic shock — "we are assuming it may be for the
same reason," Dr. Hull said.

Tissue samples from two of the patients were sent to the Centers for Disease Control and Prevention, in Atlanta, to confirm the cause of death, Dr. Hull said. Results should
be available next week. (The third patient was embalmed before samples could be taken.)

In the meantime, the Minnesota Health Department has asked all the state's hospitals and surgery centers to suspend elective knee surgery for one week.

According to a recent Mayo Clinic study, death as a result of knee surgery is extremely rare. Fewer than 2 in 1,000 people die each year from the most complicated form of
such surgery, involving total replacement of the knee.

"We don't know what the three patients had in common other than the fact that they were doing fine and then died" no more than four days after knee surgery, said Buddy
Ferguson, a spokesman for the Minnesota Health Department. "Their operations were done in two facilities in different operating rooms by different surgical teams."

On Nov. 7, the first of the patients, Brian Lykins, 23, had cartilage surgery at St. Cloud Hospital in St. Cloud. Two days later, Wayne Hulterstrum, 78, had a knee replacement
at the same hospital. Both died on Nov. 11.

On Nov. 13, the third man, 60, who was not identified, entered Douglas County Hospital in Alexandria, some 50 miles to the northwest, for a knee replacement. He died on
Nov. 16.

Two immediate questions, Mr. Ferguson said, are how the bacterium could have gotten into a hospital, and why knee surgery patients in particular were infected. Investigators
are looking at surgical supplies, he said, many of which come prepackaged.

"We're taking a close look at items associated with knee surgery," like special drapes used to isolate the knee during the operation, Mr. Ferguson said. If identical products were
used on all three patients, health officials will take swabs from unused supplies of them and try to culture any bacteria found.

If a surgical product was contaminated and distributed nationally, "you'd expect more cases of sudden unexplained deaths after routine surgery," Mr. Ferguson said.

Both the disease control centers and Minnesota health officials are now looking for such cases.

"We have asked health care providers to notify us if they have cases that resemble these," Mr. Ferguson said. "We've gotten many calls from around the country. There are
maybe a half-dozen or dozen cases that might be similar. We're interviewing people now to see if we're dealing with a similar situation. But we don't have a fourth case so far."

Clostridium sordellii is a member of the family of bacteria that cause botulism, tetanus and gangrene, said Dr. Joseph Silva Jr., dean of the School of Medicine at the University
of California at Davis. It produces spores that can last for centuries.

"The organism is not very invasive," Dr. Silva said, "but when it does get into people, it becomes a ferocious toxin factory."

Very early aggressive treatment with antibiotics, he added, can sometimes save a patient's life.

Dr. William Tipton, executive director of the American Association of Orthopedic Surgeons, in Rosemont, Ill., said he had been thinking hard about what the three patients
might have had in common.

"I doubt very much that it could be bioterrorism," Dr. Tipton said. "My best guess is that it might involve the sticky drape with a rubberized liner" that is placed over a
patient's knee during surgery.

"But we just don't know," he said. "No one has ever seen something like this occur."
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