On the literature review "early outcomes of a novel bicruciate-retaining knee system: a 2-year minimum retrospective cohort study", it was reported that, one (1) patient experienced arthrofibrosis after undergoing a bicruciate retaining (bcr) total knee arthroplasty (tka) procedure using a journey ii xr system.The event was treated by performing a full revision surgery.Patient's outcome if unknown.No further information is available.
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H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the retrospective study identified that 1 patient experienced arthrofibrosis after undergoing a bcr tka and required a full revision surgery.As of the date of this medical investigation, the requested clinical documentation has not been provided.However, analysis of the imaging was provided by the articles author(s); therefore, further analysis of the images is not required.Arthrofibrosis is a known possible post-surgical occurrence, and a component malperformance cannot be concluded based on the provided documentation.Without the requested patient specific medical documentation, further clinical factors which could have contributed to the reported event could not be definitively concluded.The patient outcomes beyond that which was reported could not be confirmed nor concluded; therefore, no further medical assessment can be rendered at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors that could contribute to the reported event include post-operative healing issue and/or patient condition.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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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