Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Code Available (3191)
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Event Date 08/03/2009 |
Event Type
Injury
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Event Description
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It was reported that patient enrolled in a clinical study underwent left femoral resurfacing procedure on (b)(6) 2005.Subsequently, patient was revised on an unknown date due to femoral loosening.A review of invoice history could not confirm the initial surgery date, nor confirm a date of revision surgery.
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Manufacturer Narrative
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The product identification necessary to review manufacturing history was not provided.Current information is insufficient to permit a conclusion as to the cause of the event.The following sections could not be completed with the limited information provided.Product identification/expiration date - unknown, pma/510(k) number - unknown, manufacture date ¿ unknown.Event is being reported to fda on one medwatch as the limited information available indicates that a revision procedure occurred.Should additional information be received regarding the procedure, the complaint will be reassessed and further medwatch reports will be submitted, if necessary.
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Manufacturer Narrative
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Event description ¿ patient was not enrolled in a clinical study.A retrospective clinical review identified the patient¿s event.
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Event Description
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As part of a retrospective clinical study, a patient was identified who underwent a left total hip arthroplasty on (b)(6) 2005.Subsequently, patient was revised on an unknown date due to femoral loosening.No further information has been provided.
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Manufacturer Narrative
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This follow-up report is being filed to relay corrected and additional information that was unknown at the time of the initial medwatch.Correction: corrected "total hip arthroplasty" to read "femoral resurfacing procedure." device product code has been corrected in this report.
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Event Description
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As part of a retrospective clinical study, a patient was identified who underwent a left femoral resurfacing procedure on (b)(6) 2005.Subsequently, patient was revised on (b)(6) 2009 due to femoral component loosening.
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Search Alerts/Recalls
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