H3, h6.Given the nature of the alleged incident, the devices, could not be returned for evaluation.The clinical/medical investigation concluded that, per complaint details, the bilateral anthem cruciate retaining study patient experienced a pulmonary thromboembolism 5 days post total knee arthroplasty and required medication therapy.Reportedly the patient is now recovered.The provided electronic clinical report forms documented the adverse event as an anticipated, mild, and non-serious adverse event and was unrelated to the study device but possibly related to the bilateral study procedure and required medication therapy with start date as (b)(6) 2019 with patient outcome documented as recovered/resolved with an end date of (b)(6) 2020.Post-operative thrombus/pulmonary thromboembolism is a known possible risk with any surgical procedure and is not indicative of a malperformance of the component(s).The patient impact beyond the reported thromboembolism with subsequent medication therapy cannot be determined.No further medical assessment is warranted at this time.A review of the production orders did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part numbers over the past 12 months and for the batch numbers based on historical data of the device did not reveal similar events for the listed devices.A review of the instructions for use documents for total knee system revealed that wound hematoma, thromboembolic diseases including venous thrombosis, pulmonary embolus, or myocardial infarction may occur as an adverse effect.A review of the risk management files revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to these products and event.At this time, we have no reason to suspect that the products failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative patient condition and/or medical history.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
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