Model Number N/A |
Device Problem
Unstable (1667)
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Patient Problem
No Code Available (3191)
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Event Date 05/23/2011 |
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, subluxation and instability were noted on (b)(6) 2010.These findings were found due to follow up monitoring, there were no symptoms reported by the patient.Subsequently, patient was revised on an unknown 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 warnings it states, "improper selection, placement, positioning, alignment and fixation of the implant components may result in unusual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components." under possible adverse effects, number 8 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." this report is number 2 of 2 mdr's filed for the same event (reference 1825034-2014-06169 and 07486).
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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 left femoral resurfacing on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2011 due to subluxation and instability.
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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 left femoral resurfacing on (b)(6) 2007.Subsequently, the patient experienced subluxation and instability, noted on (b)(6) 2010.Patient was revised on an unknown date.
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Search Alerts/Recalls
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