The reported event regarding a bone marrow edema of the hindfoot after four months from subtalar joint arthroereisis (sta), which was solved with physical therapy, could not be confirmed, since the device(s) were not returned for evaluation and no other additional information was received from the clinical site.More detailed information about the patient's medical history, the event details and the involved device(s) must be available to determine the root cause. if any additional information becomes available, the investigation will be reopened and re-evaluated accordingly.
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The post market clinical team has conducted a follow-up report on ¿radiographic clinical observational study on patients treated for flat foot ¿.The study was conducted at ¿irccs istituto ortopedico galeazzi, italy¿.The report is associated with the stryker ¿futura conical subtalar implant system (csi) ¿ and includes an analysis of the clinical data that was collected on 40 patients.The cases in the study range from january 2005 to may 2016.The report indicates that 1 patient experienced one bone marrow edema of the hindfoot after four months from subtalar joint arthroereisis (sta), which was solved with physical therapy.
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