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Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Neuropathy (1983); Pain (1994); Ambulation Difficulties (2544)
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Event Type
Injury
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 5 states, "temporary or permanent nerve damage may result in pain and numbness." number 20 states, "persistent pain." remains implanted.
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Event Description
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It was reported that patient underwent bilateral partial knee arthroplasties on an unknown date.Subsequently, patient reported, at nineteen months post-op, experiencing occasional pain in both knees and walks with a cane mostly due to back problems, drop foot, and neuropathy.A revision procedure has not been indicated at this time.
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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.Review of device history records show that lot released with no recorded anomaly or deviation.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2016-00973 / 01406).
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Event Description
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It was reported that patient underwent bilateral partial knee arthroplasties on (b)(6) 2012.Subsequently, patient reported, at nineteen months post-op, experiencing occasional pain in both knees and walks with a cane mostly due to back problems, drop foot, and neuropathy.A revision procedure has not been indicated at this time.
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Search Alerts/Recalls
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