Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Arthritis (1723)
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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) 2005 due osteoarthritis.Subsequently, patient experienced two anterior dislocations and two posterior dislocations, which were treated by closed reductions.No revision procedure was reported.
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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 8 states, ¿dislocation and subluxation due to inadequate fixation and improper positioning.¿ this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2014-05996 / -05997).
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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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Manufacturer Narrative
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Corrected data: 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) 2005 due to osteoarthritis.Subsequently, patient experienced two anterior dislocations and two posterior dislocations, which were treated by closed reductions.No revision procedure has been reported.
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Search Alerts/Recalls
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