Correction: please refer to h6 method, results & conclusion codes.The reported event could partially be confirmed, since x-rays and operative reports were provided.Since x-rays were provided, the opinion of medical experts was requested.Their statement concerning this case is the following: " [¿] after reviewing the patient¿s charts and looking at the x-rays we concluded the following.The good temporary clinical result of the cortisone injection into the ankle joint in the postoperative period, makes it plausible the source of the patient¿s complaints lies intra-articular (i.E., in the patient¿s left ankle joint with the tar).The postoperative x-rays show some residual infringement on the medial aspect of the left fibula, most likely related to slight oversizing of the tibial component.There are indeed no signs of tibial component subsidence, loosening and/or migration.Impingement/ pain like complaints are not uncommon after tar [¿].Choosing the appropriate size for the patient is a matter of surgical expertise and experience in the device at hand.This may or may not entirely explain the patient¿s complaints.At this point in time, it is impossible to conclude with certainty that the slight oversizing is the source of the patient¿s complaint.The result of the revision may help to clarify this in retrospect.[¿]" based on the statement above, the inadequate sizing of the tibial component could be one of the probable root causes of the pain experienced by the patient.It is important to state that it is the user's responsibility to select the right sizing of implant to fit the patient's anatomy.The ifu clearly states that a proper sizing is key to a good clinical outcome.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 more information is provided, the case will be reassessed.
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