Catalog Number 5532-G-311 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Injury (2348); Fluid Discharge (2686)
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Event Date 05/24/2016 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was sent to pathology and was not returned to the manufacturer.Additional information 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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Dr.(b)(6).Reports patient (b)(6).Status post right knee revision(poly exchange) done on (b)(6) 2016 has a small draining sinus tract.Dr.(b)(6).Decided he wanted to wash out and debride the surgical site and change the poly again.After washing out the surgical site he exchanged the poly to a 13mm thick ps insert.The surgical site was closed.The surgery was performed without incidence.
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Manufacturer Narrative
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Reported event: an event regarding revision involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: no medical records or x-rays were made available for evaluation.-device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies -complaint history review: there has been no other event for the lot referenced.Conclusions: the event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Product surveillance will continue to monitor for trends.
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Event Description
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Dr.(b)(6) reports patient (b)(6) status post right knee revision(poly exchange) done on (b)(6) 2016 has a small draining sinus tract.Dr.(b)(6) decided he wanted to wash out and debride the surgical site and change the poly again.After washing out the surgical site he exchanged the poly to a 13mm thick ps insert.The surgical site was closed.The surgery was performed without incidence.
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Search Alerts/Recalls
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