Model Number N/A |
Device Problems
Unstable (1667); Insufficient Information (3190)
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Patient Problems
No Information (3190); No Code Available (3191)
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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.Date of birth - 1934.
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Event Description
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It was reported that patient enrolled in a clinical study underwent an initial right oxford knee procedure on (b)(6) 2014.Patient reported a feeling of the knee "giving way" on (b)(6) 2014.No revision has been reported.
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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.Remains implanted.
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Search Alerts/Recalls
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