The reported event could not be confirmed.Device evaluation: the tibial & talar components have been returned with bits of bones attached to it, which confirms that osseointegration has been achieved.The device itself does not show any traces of deformation of the material or major scratches or breakage.Some scratches can be noticed on the sides of the device, but nothing that could compromise its functionality.The x-rays having been provided, the opinion of a medical expert has been requested.Their statement is as follows: ¿[¿] it seems as if there is loosening of the tibial component.From the given ap-view one could assume, that a little bit of lateral settling of the component also has taken place.There are also some cysts to be guessed at the lateral part of the tibial component.I would recommend further investigations maybe including a puncture and a scintigraphy.[¿]¿ as a conclusion, the loosening of the tibial component as well as the potential presence of some cysts could be considered as the root cause of the pain that the patient underwent.Based on the available information a deficiency of the devices in question could be discarded.In case any relevant clinical information should become available, we reserve the right to update the investigation and change the root cause.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If any further information is provided, the investigation report will be updated.
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