Catalog Number 690-00-22E |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Code Available (3191)
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Event Date 01/27/2014 |
Event Type
Injury
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Event Description
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Trident constrained liner disassociation.Patient had revision surgery (b)(6) 2011.Liner failure one week prior to surgery on (b)(6) 2014.
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was retained by the surgeon and was not returned to the manufacturer.Additional information (including x-rays and medical records) has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.Not returned to the manufacturer.
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Event Description
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Trident constrained liner disassociation.Patient had revision surgery (b)(6) 2011.Liner failure one week prior to surgery on (b)(6) 2014.
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Manufacturer Narrative
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Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no reported discrepancies.Complaint history review: there have been no other events reported for the reported manufacturing lot the event could not be confirmed nor the root cause of the reported event determined due to the minimal information received.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.
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Search Alerts/Recalls
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