Model Number N/A |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
Thrombosis (2100)
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Event Type
Injury
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Event Description
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It was reported that patient enrolled in a clinical study underwent a left femoral resurfacing procedure on (b)(6) 2009.During post-operative monitoring, deep vein thrombosis was noted on (b)(6) 2009.These findings were found due to follow up monitoring, there were no symptoms reported by the patient.There has been no reported revision procedure to date.
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Manufacturer Narrative
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Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly.
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Manufacturer Narrative
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The follow-up report is being filed to relay corrected information that was unknown at the time of the initial medwatch.Event description ¿ patient was not enrolled in a clinical study.A retrospective clinical review identified the patient¿s event.
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Event Description
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As part of a retrospective clinical study, a patient was identified who underwent a left femoral resurfacing procedure on (b)(6) 2009.Subsequently, the patient experienced a deep vein thrombosis, which was noted on (b)(6) 2009.These findings were found due to follow up monitoring, there were no symptoms reported by the patient.There has been no reported revision procedure to date.
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Search Alerts/Recalls
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