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The associated journey ii bcs bcs oxinium femoral component, journey ii bcs articular insert and journey tibia baseplate were not made available for evaluation.Therefore a product inspection could not be performed.However, device details were provided and the review of the manufacturing records and complaint history was conducted.The review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.The review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.There is no information that would suggest the implanted devices failed to meet specifications.A relationship, if any, between the devices and the reported incident or adverse event could not be corroborated.Our clinical evaluation noted that no relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time and the patient impact beyond the reported arthrofibrosis cannot be determined.Without the return of the actual product involved, our investigation of this report is inconclusive.We will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.Mimb review.Assess severity of complaint case to determine if additional actions or inputs are required for inclusion in the medical assessment.Determine if a medical assessment will be performed based on a review of the complaint details and further input from the medical director/designee.No clinically relevant supporting documentation was provided; therefore a thorough medical investigation could not be performed.Should clinical documentation become available in the future, the clinical/medical task may be re-evaluated.No further medical assessment is warranted at this time.A review of relevant clinical/medical information in the reported issue, inclusive of technique and patient information, to include, but not limited to: ¿patient information ¿surgical procedure/post-operative care review ¿device labeling (including technique guides, ifus, etc.) it was reported that the patient presented arthrofibrosis after total knee arthroplasty on his left knee.Arthrofibrosis is a known possible complication after surgical intervention.Although the s&n devices cannot be excluded as to have caused or contributed to the reported event.No relevant supporting clinical information has been provided to assist with a clinical investigation.Therefore, based on insufficient information, a thorough clinical assessment cannot be performed at this time and the patient impact beyond the reported arthrofibrosis cannot be determined.
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