Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Scar Tissue (2060); No Code Available (3191)
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Event Date 01/19/2016 |
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.
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Event Description
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It was reported that patient underwent a partial knee arthroplasty on (b)(6) 2014.Subsequently, a revision procedure was performed on (b)(6) 2016 due to unknown reasons.During the procedure, the polyethylene tibial bearing was removed and replaced.
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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 a knee revision procedure approximately twenty (20) months post-implantation due to scar tissue.During the procedure, the tibial bearing was removed and replaced, and scar debridement occurred.
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Search Alerts/Recalls
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