Index surgery: (b)(6) 2018.Revision due to infection.Patient had a slow-healing wound on left anterior ankle that progressed to a deep infection in the ankle joint.On (b)(6) 2018, the vantage implant was removed, and an antibiotic spacer was placed.The case report form indicates this event is definitely not related to devices and definitely related to procedure.On (b)(6)2018, patient came in with sepsis with fever, tachycardia, rigors, leukocytosis, and relative hypotension.The case report form indicates this event is definitely not related to devices and definitely related to procedure.On (b)(6) 2018, patient was seen again and was weaning out of cam boot and compression stocking; continuing on oral antibiotics daily.The case report form indicates this event is definitely not related to devices and definitely related to procedure.
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