The alleged complaint could not be confirmed.This patient was indicated to have been revised due to stiffness approximately 43 months after the primary operation.All components were revised.The revised products were not returned to microport, and no radiographs or operative notes were provided to confirm this complaint.Review of the device history record for this lot indicates that this product met all acceptance criteria at the time of manufacturing.The microport knee systems package insert (150806-2) lists "inadequate range of motion due to improper selection or positioning of components, periarticular calcification, flexion contracture" as a possible adverse effect of total knee arthroplasty.There were no trends identified per mpo trending procedures.No further conclusions can be made from the available information.This issue will continue to be monitored through complaint tracking.Methods: device not returned.Analysis of production records.Trend analysis.Results: no findings available.Conclusions: device met specification.Device was used for treatment.Known inherent risk of device.
|