Pt weight, ethnicity and race information was not supplied by reporter.Although pulmonary embolism occurs at a known rate postoperatively following joint replacement surgery, including knee arthroplasty, this was the 4th pulmonary embolism event reported to 3m from this study.This seems to be a slightly higher prevalence rate than expected but we do not know if it is statistically significant.3m contacted the study investigators to obtain additional patient details regarding operative duration, patient comorbidities and medical history.No additional information has been received to date.(b)(4).There was no conclusive evidence that the occurrence of a pulmonary embolism was related to the use of 3m coban 2 lite layer compression system post total knee arthroplasty.3m will continue to monitor complaints and trends for this type of report.
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3m received a formal letter from the university of (b)(6) regarding their investigation of the four pulmonary embolisms that occurred within the investigator-initiated research study entitled "the use of 3m¿ coban¿ 2 lite layer compression system post-total knee arthroplasty".The university (b)(6) consulted with two independent content experts to investigate the etiology of the pulmonary embolisms and to determine whether they were related to the study intervention, i.E., the 3m¿ coban¿ 2 lite layer compression system.In brief, the independent content experts reached consensus that the four pes were likely unrelated to the study intervention 3m¿ coban¿ 2 lite layer compression system.
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