Correction - h6 (results code, conclusion code) the reported event could be confirmed, based on available information, ct scans and medical expert opinion.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, healthcare professionals opined that- " tibial (construct): there is radiolucence and some potential subsidence visible in the provided ct scan.That is supported by the clinical information given to the case and therefore loosening and migration can be confirmed.Pe: no issues, attached to the tibial tray.Talar (construct): the talus shows some radiolucence, but there seems to be no loosening or migration according to the clinical information given in this case.Full tar (construct): the loosening and migration seems to be caused by the poor bone substance and has to be assessed as being patient related." based on investigation, the root cause was attributed to a patient related issue.The failure was caused by poor bone substance which contributes to lack of stability of implant.If device is returned or any further information is provided, the investigation report will be reassessed.
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