Correction - h6 (results code).The reported event could be confirmed, based on available ct scans and medical expert assessment.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.Upon further investigation of the ct scans by healthcare professionals the following was observed "tibial (construct): there is radiolucence visible and there are smaller cysts at the anterior part of the tibial component.Additionally, it looks as if there was a crack in the anterior tibial tray.Therefore loosening and anterior subsidence can be confirmed and there is a potential breakage of the prosthesis (to be confirmed via x-ray-here: insufficient information.) pe: the pe is not separated from the tibial tray.There is no indirect sign of loosening, but it cannot be excluded completely, that damage or dislocation of the pe has taken place.There is insufficient information given, here.Talar (construct): the talar component shows little radiolucence anteriorly.However, there is no clear sign of loosening or migration." based on the available ct scans, cysts around tibial component is observed.Additionally, potential crack of tibial tray is observed in ct scans.However, more detailed information about the complaint event, x-rays 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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