Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Swelling (2091)
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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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 20 states, ¿persistent pain.¿ device remains implanted.
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Event Description
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It was reported that patient underwent left partial knee arthroplasty on an unknown date.It was further reported that patient experienced left knee pain with swelling.
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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 left partial knee arthroplasty on (b)(6) 2012.It was further reported that patient experienced left knee pain with swelling.
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Search Alerts/Recalls
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