Model Number N/A |
Device Problem
Loose or Intermittent Connection (1371)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/04/2008 |
Event Type
Injury
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Event Description
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It was reported that patient enrolled in a clinical study underwent a left femoral resurfacing procedure on (b)(6) 2007.During post-operative monitoring, a loose femoral component was noted on (b)(6) 2008.These findings were found due to follow up monitoring, there were no symptoms reported by the patient.There has been no reported revision procedure to date.
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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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 4 states, "loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.".
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Manufacturer Narrative
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Corrected data: 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 femoral resurfacing procedure on (b)(6) 2007.During post-operative monitoring, a loose femoral component was noted on (b)(6) 2008.These findings were found due to follow up monitoring.There has been no reported revision procedure to date.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch.
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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) 2007.Subsequently, a revision procedure was performed on (b)(6) 2008 due to a loose femoral component.The femoral component was removed and replaced.
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Search Alerts/Recalls
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