Allegedly, reporter became aware of some nitrx complaints from a surgeon in idaho however, no information about the complaints were given to reporter.Microport orthopedics vp r&d prod.Development stated that he received a phone call from mike shatzer(sales rep) saying that a doc in idaho had a few patients come back in with painful, swollen knees.He contacted the rep to see if he could get more details.He asked a series of questions that he did not know the answer.No part/lot numbers are given and it has not been indicated how many events/patients have occurred regarding these issues.Additional information received on (b)(6) 2022: a total of 8 complaints were received.The 7 remaining complaints are captured under different microport incident group numbers.Allegedly, recurring knee effusion.No infection to date.It was confirmed that each of these patients were seen for follow-up appointments to address inflammation in their knees.The surgeon confirmed that none of the patients had infections and that their knees had fluid buildup that was drained.The surgeon has not been able to determine if these events were caused by an alleged deficiency/failure against these devices or if they were caused due to patient conditions.It is indicated that there is no access to information regarding each patient's condition, activity level, medical history, etc.Incident form received contains two evolution® mp? cs inserts however only one insert(eis3s10l) is indicated as a revised component.The other insert indicated in the form is: eis3s12l, evolution® mp? cs insert size 3 standard 12mm left, lot number: 1708616, qty:1.Also, there has been an instrument (k0001288, advance® evolution® pin pack 3 long & 2 collared sterile, lot: 1883110) mentioned on the incident form, however there is no complaint stated against this instrument.
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