Adverse Occurrence type:
The authors estimated the rate of infection by clostridium using tendons from the implicated substandard tissue bank was 0.1% and for femoral condyles 0.36%.
Time to detection:
2 - 85 days
Alerting signals, symptoms, evidence of occurrence:
23 year old male received fresh femoral condyle during reconstruction knee surgery in 2001 in Minnesota, USA. Developed knee pain on postop day 3 that progessed to shock and death at postop day 4. The US CDC sought and received reports of infections in knee surgeries using tendon (9 patients), frozen femoral condyles (4 patients), fresh femoral condyle (i patient) or meniscus (1 patient) allografts at US hospitals and other facilities during 1998-March 2002. They reported on clostridium infections in 14 patients ( 12 with C. septicum, 1 with C. bifermentans and one fatal infection with C. sordelli). All required hospitalization, IV antibiotics, joint irrigation and debridement. Ten required allograft removal; three needed knee arthroplasty; and 3 were disabled unable to work. All implicated allografts were not sterilized but were processed in a substandard fashion by a single tissue bank. C septicum and C sordelli grew from unused allografts from 3 of 4 implicated donors. There were no infections reported in patients who used a larger number of tissues from these same donors but had been processed at other U.S. tissue banks using sterilization methods.
Demonstration of imputability or root cause:
Level 4: Certain for most patients since the same clostridium found in the patient was also found in unused allografts from the donor. For the minority of patients transmissibility is Level 3: Probable: infected allografts in different patients came from common donors, processing antibiotics were ineffective for clostridium, final sterility testing method was insensitive.