Model Number N/A |
Device Problem
Device Slipped (1584)
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Patient Problem
No Code Available (3191)
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Event Date 07/28/2014 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a left partial knee arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2014 due to laxity.The bearing was removed and replaced.
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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 18 states,"patellar tendon rupture and ligamentous laxity.".
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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.This medwatch, 1825034-2014-07265, is a duplicate of medwatch 1825034-2014-07196.
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Search Alerts/Recalls
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