STRYKER ORTHOPAEDICS-MAHWAH NO 4. TRIATHLON TS PLUS TIBIAL INSERT X3 POLY 28MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5537-G-428 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Discharge (2225)
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Event Date 06/29/2016 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as device was retained at drexel implant research center.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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The arthroplasty was revised due to drainage, elevated white blood cell count.The insert component was revised.
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Manufacturer Narrative
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An event regarding revision with abnormal ion levels involving an triathlon insert was reported.The event was not confirmed.Method and 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: the provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.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.
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Event Description
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The arthroplasty was revised due to drainage, elevated white blood cell count.The insert component was revised.
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Search Alerts/Recalls
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