Catalog Number 320-38-03 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); No Code Available (3191)
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Event Date 11/24/2014 |
Event Type
Injury
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Manufacturer Narrative
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Pending evaluation.
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Event Description
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Index surgery: (b)(6) 2014.Revision due to dislocation that was discovered in x-rays at 2 week follow-up visit.The case report form indicates this event is definitely not related to devices or procedure.This event report was received through clinical data collection activities.
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Manufacturer Narrative
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Engineering evaluation noted that the revision was likely the result of dislocation, which is addressed in the product labeling under device specific risks.
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Event Description
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Index surgery: (b)(6) 2014.Revision due to dislocation.The case report form indicates this event is definitely not related to devices or procedure.This event report was received through clinical data collection activities.
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Search Alerts/Recalls
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