Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Swelling (2091); Ambulation Difficulties (2544)
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Event Type
Injury
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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 or deviation.The following sections could not be completed with the limited information provided: implant date - approximately 3 years ago.Product location unknown.
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Event Description
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It was reported that patient underwent a left partial knee arthroplasty approximately 3 years ago.Subsequently, patient experienced swelling.It was further reported that patient had a large brain tumor removed which has affected balance and the ability to manipulate her legs.No further information has been provided.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.
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Event Description
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It was reported that patient underwent a left partial knee arthroplasty on (b)(6) 2011.Subsequently, patient experienced swelling.It was further reported that patient had a large brain tumor removed which has affected balance and the ability to manipulate her legs.No further information has been provided.
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Search Alerts/Recalls
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