The reported event could be confirmed with the help of medical documents provided.The device inspection was not possible as the product was not returned for investigation.The device history record could not be reviewed because the affected device was not returned, and the lot number was not communicated.A review of the labeling did not indicate any abnormalities.The instructions for use instructs user that: ¿improper selection, placement, positioning, and fixation of the prosthetic components may result in unusual stress conditions and a subsequent reduction in service life of the prosthetic component.Periodic, long-term follow-up is recommended to monitor the position and state of the prosthetic components, as well as the condition of the adjoining bone.¿ formal medical opinion was sought from an experienced independent medical expert as below; ¿the images show some radiolucencies around the components, albeit no signs of obvious loosening of the implant.There is, however, some medial displacement of the tibial component relative to the tibial component, indicating either soft tissue insufficiency leading to instability or asymmetric wear if the polyethylene component (insert) or both.Retrieval of the implant and/or a detailed description of the retrieved components will allow for further assessment.¿ more detailed information about the complaint event as well as the affected device must be available in order to determine the root cause of the complaint event.If device is returned or any further information is provided, the investigation report will be reassessed.
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