Model Number N/A |
Device Problem
Fracture (1260)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/24/2009 |
Event Type
Injury
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Event Description
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It was reported that patient enrolled in a clinical study underwent a right femoral resurfacing procedure on (b)(6) 2009.Subsequently, patient experienced a femoral neck fracture.There has been no reported revision procedure to date.An invoice history could not be located to confirm the surgery 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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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.Subsequently, patient was revised on (b)(6) 2009 due to a femoral neck fracture as a result of patient noncompliance.
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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, malalignment, trauma, non-union, or excessive weight.".
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Manufacturer Narrative
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Ifu: there are warnings in the package insert that state that this type of event can occur: under possible adverse effects, 14 states, ¿intraoperative or postoperative bone fracture of the femoral neck and/or postoperative pain.¿.
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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 right femoral resurfacing procedure on (b)(6) 2009.Subsequently, the patient experienced a femoral neck fracture as a result of patient noncompliance.Patient was revised on (b)(6) 2009.
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Manufacturer Narrative
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This follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.
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Search Alerts/Recalls
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