Correction d6a the reported event could not be confirmed since the device was not returned for evaluation and no other evidences were provided.Medical profession reviewed the received information and noted: the x-rays from (b)(6) 2022 show a subluxation (partial dislocation) of the left ankle joint.This has to do with a lack of soft tissue support, creating instability of the left ankle joint.As a result, parts of the talar component articulates with the tibial bone, causing deformation of the bone and the formation of a neo-articulation.In this situation, asymmetrical loading of the polyethylene insert will have damaged this component without doubt.The x-rays from (b)(6) 2022 show that at this moment in time the tibial component is well fixed, as indicated by the bone on growth at the proximal tip of the inbone stem.The tibial device construct looks intact.Still, there is no comparison possible with the initial position of the implant in 2012.So, whether it has subsided cannot be assessed with one moment in time available on x-rays.Without doubt the polyethylene inlay is either deformed or broken or dislodged, or a combination of this.The most posterior one of the talar baseplate fusion rod (500004945) is broken, on the x-rays from (b)(6) 2022.The others are intact, providing enough support to the talar component.Since the fusion rod is crossing the subtalar joint, it can be associated with some residual movement in the subtalar joint, or with some subsidence of the talar component.Still, there is no comparison possible with the initial position of the implant in 2012.So, whether it has subsided cannot be assessed with one moment in time available on x-rays.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.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 the device is returned or if any additional information is provided, the investigation will be reassessed.
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