Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Complaint, Ill-Defined (2331)
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Event Date 02/21/2014 |
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 right femoral resurfacing procedure on (b)(6) 2009.During post-operative monitoring, unspecified surgical complications were noted on (b)(6) 2014.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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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.(b)(4).
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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 right femoral resurfacing procedure on (b)(6) 2009.Subsequently, patient experienced other surgical complications.No revision has been reported.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 additional information, which was unknown at the time of the initial medwatch.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.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 9 states, ¿fatigue fracture of component can occur as a result of loss of fixation, strenuous activity, alignment, trauma, non-union, or excessive weight.
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Event Description
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As part of a retrospective clinical study, a patient was identified who underwent a right femoral resurfacing procedure on (b)(6) 2009.Subsequently, patient experienced other surgical complications.No revision has been reported.No further information has been provided.Additional information received revealed patient experienced a femoral head fracture due to a fall, twisting leg, and walked with a limp.Subsequently, patient was revised on (b)(6) 2014.Product identification is now known.
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Search Alerts/Recalls
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