Model Number N/A |
Device Problems
Malposition of Device (2616); Positioning Problem (3009)
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Patient Problems
No Information (3190); No Code Available (3191)
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Event Date 10/27/2015 |
Event Type
Injury
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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, number 1 states, ¿improper selection, placement, positioning, alignment and fixation of the implant components may result in un usual stress conditions which may lead to subsequent reduction in the service life of the prosthetic components.¿.
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Event Description
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It was reported that patient had an initial left partial knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised to a total knee on (b)(6) 2015 due to malposititon.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.
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Event Description
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It was reported that patient had an initial left partial knee arthroplasty on (b)(6) 2014.Subsequently, patient was revised to a total knee on (b)(6) 2015 due to malposititon of the tibial tray.No further information has been provided.
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Manufacturer Narrative
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This follow-up report is being filed to correct information.
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Search Alerts/Recalls
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