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Catalog Number 200011901 |
Device Problem
Migration or Expulsion of Device (1395)
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Patient Problems
Pain (1994); Inadequate Pain Relief (2388)
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Event Date 05/30/2016 |
Event Type
malfunction
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Manufacturer Narrative
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This is a reportable malfunction.No revision surgery has occurred to date.The investigation is not complete.Trends will be evaluated.This report will be updated when the investigation is complete.This is the same event as 1043534-2016-00054, 00056, 00057, 00058, 00059, 00060.
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Event Description
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Allegedly, the patient had a total ankle replacement.Her surgery was in (b)(6) 2012.She continued to have periodic pain with her ankle but was able to manage and walk.However, the pain has grown intense and instead of frequently, it is all the time.She has visited her surgeon and he has given her shots and injections to calm the pain but nothing has helped, if anything it has become worse.From her x-rays he has determined that the insert in her bone in her leg is moving causing friction and probably the greatest amount of her pain.
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Manufacturer Narrative
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This incident is considered closed.If at any time new or updated information becomes available, the incident will be re-opened and investigated.
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Search Alerts/Recalls
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