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Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Type
Injury
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Event Description
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It was reported that a patient was scheduled to undergo an eleos distal femoral replacement with proximal tibia.However, the revision surgery was cancelled due to an unknown reason.The revision surgery has not been rescheduled.No additional information is known at this time.This event will be reportable to the fda as a serious injury due to the scheduled revision procedure.
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Event Description
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It was reported that a patient was scheduled to undergo an eleos distal femoral replacement with proximal tibia.However, the revision surgery was cancelled due to an unknown reason.The revision surgery has not been rescheduled.No additional information is known at this time.This event will be reportable to the fda as a serious injury due to the scheduled revision procedure.
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Manufacturer Narrative
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It was reported that a patient was scheduled to undergo an eleos distal femur with proximal tibia revision.It was further communicated that this revision surgery was cancelled due to an unknown reason and has not been rescheduled.The reason for the revision surgery is also unknown.The root cause for this event could not be determined.A review of the work order and sterilization batch release record for the product involved could not be performed as the product information is unknown.Device evaluation, device history review, risk documentation, ncr history, and complaint history could not be reviewed as event details are unknown.If additional information is received regarding this event, a supplemental will be sent accordingly.
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Search Alerts/Recalls
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