Model Number N/A |
Device Problems
Migration or Expulsion of Device (1395); Malposition of Device (2616)
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Patient Problem
No Code Available (3191)
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Event Type
Injury
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Manufacturer Narrative
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The warnings in the package insert state this type of event can occur.The lot number is unknown; therefore the device history records are unable to be reviewed.The user facility is foreign; therefore a facility medwatch report will not be available.Current information is insufficient to permit a valid conclusion about the cause of this event.If additional information is obtained that adds value to the relevant content of this report and/or a conclusion can be drawn, a follow-up report will be sent.Report two of eleven for the same event, reference 1032347-2015-00460 through -00470.
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Event Description
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The distributor reported a revision is planned for (b)(6) 2015 due to the prosthesis shifting to the right.She reported in (b)(6) 2008 the right prosthesis was placed , and in (b)(6) 2010 the left prosthesis was placed.The surgeon was inquiring on the possibilities of relocating the same prosthesis during the revision surgery, however we advised these implants are single use.
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Manufacturer Narrative
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Additional information was received from the sales associate, she stated the revision surgery was performed (b)(6) 2015.She stated the implants were removed and replaced with new implants.It is reported the explanted devices were discarded.In addition, she reported the revision surgery was perfect and the patient is doing perfectly now.Supplemental report two of eleven for the same event, reference 1032347-2015-00460-1 through -00470-1.
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Search Alerts/Recalls
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