Allegedly, reporter became aware of some nitrx complaints from a surgeon in (b)(6) 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 and (b)(6) 2022: a total of 8 complaints were received with all relevant information included in each incident form.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.It was indicated that the insert implanted in his left knee has been revised.No indications of revision surgery performed for the other components have been given yet.This patient has components implanted in both knees (right and left) however it was indicated that only the components implanted in his left knee have the alleged complaint stated above.The following components were implanted in his right knee.None of these components have been revised and they have not an alleged deficiency against them: product id: efsrn6pr, evolution®mp fem cs/cr non-por size 6 primary right, lot: 1788038, qty:1.Product id: etpkn6sr, evolution®mp tib keeled nonpor size 6 standard right, lot: 1779056, qty:1.Product id: eis6s10r, evolution® mp? cs insert size 6 standard 10mm right, lot: 1780477, qty:1.Product id.Kpontp35, advance® onlay all-poly patella 35mm tri-peg, lot: 1780113, qty:1 also, the following instrument was used in his left knee implant surgery without any complaint stated against it: product id: k0001288, advance® evolution® pin pack 3 long & 2 collared sterile, lot: 1790445, qty:1.
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