Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Code Available (3191)
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Event Date 06/25/2014 |
Event Type
Injury
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Event Description
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It was reported that patient underwent right partial knee arthroplasty on (b)(6) 2013.Subsequently, a revision procedure was performed on (b)(6) 2014 to remove and replace all components with a total knee system for an unknown reason.
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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.
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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 right partial knee arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2014 due to unspecified complications on the lateral side of the patient's knee.All components were removed and a total knee system was implanted.
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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 right partial knee arthroplasty on (b)(6) 2013.Subsequently, patient was revised on (b)(6) 2014 due to unspecified complications on the lateral side of the patient's knee.All components were removed and a total knee system was implanted.Additional information received noted patient was revised on (b)(6) 2014 due to disease progression.
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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined to be not reportable.The initial report was forwarded in error and should be voided.
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Search Alerts/Recalls
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