The reported event could not be confirmed, since the device was not returned for evaluation and no other evidences were 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.Formal medical opinion was sought an experienced independent medical expert based on available ct scan and primary tar report.His response is as below- ¿the ct scan shows status after a lower leg fracture that has healed completely, yet somewhat malunited, causing malalignment of the distal third of the tibia.The was already the case before the primary tar in 2014.The tibia component is well-fixed and is misaligned to the mechanical axis of the leg, but well-aligned in relation to the distal tibia.It has subsided a little (this is usually the case within two years after implantation).The joint line is asymmetric, this can be caused by asymmetric pe-liner wear, or by joint instability or the combination of both.For assessment, the retrieval of the pe-liner would be necessary.The talar component looks well-fixed as well, it looks like it has subsided somewhat medially.Furthermore, there are degenerative changes of the subtalar, talonavicular and calcaneocuboid joints.Further clinical information is required to assess the root cause (indication) for revision.¿ 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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