Correction: clinical code, device code, result code, conclusion code.The reported event could be confirmed based on available medical record 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: ¿the ct-scan shows subsidence of the tibial component, it is not loose, however.The structure of the bone is osteopenic (hypertrophy of the vertical trabeculae, atrophy of the other trabeculae).No relevant bone changes around the talar component (yet the whole skeleton looks osteopenic).¿ based on investigation, the root cause was attributed to a patient related issue.The failure was caused due to osteopenic bone of the patient which induces instability of implant resulting in its subsidence.If device is returned or any further information is provided, the investigation report will be reassessed.
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