RTIX info 1/18 issue of orthopedicstoday.com Postsurgical infection and septic arthritis traced to allograft tissue
The CDC is investigating several cases of infections in patients who had allograft tissue implanted.
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January 2002
ATLANTA — Infections in knee surgery patients were linked to allograft tissue used in their procedures, the Centers for Disease Control and Prevention (CDC) recently reported in its Morbidity and Mortality Weekly Report.
Four patients developed postsurgical septic arthritis in 2000 after undergoing anterior cruciate ligament (ACL) reconstruction with bone-tendon-bone allografts from tissue banks in Texas and Florida.
The cases came to light after a 23-year-old Minnesota man underwent an articular cartilage graft procedure using allograft tissue in November 2001 and died four days later. Blood cultures obtained from the patient before his death contained Clostridium sordellii, a rare bacterium. Minnesota Department of Health officials determined that the infection resulted in the patient’s death.
The donor condyle tissue was proven to be the source of the infecting pathogen, said Marion Kainer, MD, MPH, epidemic intelligence service officer at the CDC, which is investigating the cases. Kainer would not identify the tissue bank that supplied the cartilage graft, but said that it did provide the CDC with several tissue samples from the donor. Cultures showed the presence of C. sordelli, the CDC said.
Cryolife Inc. of Kennesaw, Ga., processed the allograft tissue used in the Minnesota man’s surgery, as well as others, said company spokesperson Roy Vogeltanz. He said the company is cooperating with the Minnesota Department of Health, CDC and the Food and Drug Administration.
“Tissues from the same donor processed by Cryolife Inc. have been implanted in eight other patients. Physician follow-ups on these patients have indicated they are all doing well,” James C. VanderWyk, PhD, Cryolife’s vice president of regulatory affairs and quality assurance, said in a statement.
Kainer said none of the patients who received a variety of knee allografts from the same donor as the Minnesota man have died. “One of those recipients did develop a knee infection. That patient is being treated with antibiotics and is improving. The tissue bank involved has been cooperative. It’s one piece within this whole investigation. We need to look at the donor, the procurement, the tissue processing at the tissue bank.”
Pseudomonas aeruginosa, Staphylococcus aureus and Enterococcus faecalis were cultured from knee aspirate or surgical site tissues from two patients in Florida in April 2000. Their bone-tendon-bone allografts for ACL reconstruction were from a common donor and were provided by a Texas tissue bank, which the CDC did not identify. Both patients subsequently developed septic arthritis in the operated knee. Septic arthritis a rare complication of knee surgery, especially of ACL reconstruction, the report said.
In October 2000, bone-tendon-bone allografts resulted in septic arthritis in two patients in Florida and Louisiana. Those allografts were from a common donor, the CDC reported. They were processed by Regeneration Technologies in Alachua, Fla. Spokesperson Quenta Vettel told ORTHOPEDICS TODAY that the company conducted a trace-back investigation immediately after the problem was discovered. They found that the tissue had been released before undergoing terminal sterilization with gamma irradiation.
“We went back in and reviewed these two cases and added several preventative measures to the data entry system to further safeguard against the inadvertent release of tissue. We did a full review of all the tissue that was in-house at the time” and concluded that the cases were isolated, Vettel said.
A statement from the American Association of Tissue Banks (AATB) called the CDC reports “very disturbing.” AATB is a nonprofit scientific professional organization that accredits tissue banks to assure that human tissues used in transplantations are safe and free of infectious diseases.
According to the AATB’s Web site, neither Cryolife nor Regeneration Technologies are accredited by the association. Vogeltanz said Cryolife is not a member of the AATB because it consists of competing tissue processors.
The AATB statement said that while the ACL infection cases are “tragic,” they represent only four of the 750,000 allografts distributed for transplantation in 1999 (.0005%). Cryolife said the company has processed tissue from over 60,000 donors in 17 years without a known incident of C. sordelli infection.
Clinicians should consider possible clostridial infection in patients with evidence of infection following allograft implantation, the CDC report said. Signs of sepsis, as well as fever, hemodynamic compromise and/or major abdominal pain should be looked for during clinical evaluation.
Documented or suspected cases should be reported to CDC’s Division of Healthcare Quality Promotion, (800) 893-0485. |
