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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 09/01/2015 |
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.".
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Event Description
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It was reported that patient underwent left partial knee arthroplasty on (b)(6), 2014.Subsequently, patient was revised to total knee on (b)(6), 2015 due to pain.
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Manufacturer Narrative
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This follow-up report is being filed to correct information and to relay additional information, which was unknown at the time of the initial medwatch.Not returned by patient.
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Search Alerts/Recalls
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