STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT #6 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5531G609 |
Device Problems
Unintended Movement (3026); Insufficient Information (3190)
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Patient Problems
Injury (2348); No Code Available (3191)
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Event Date 11/30/2015 |
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 retained by the hospital 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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Unstable total knee converted knee to a posterior stabilized construct.
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Manufacturer Narrative
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An event regarding instability involving a triathlon insert was reported.The event was confirmed through operative notes.Method & results: device evaluation and results: not performed as product was not returned.Medical records received and evaluation: medical review indicated: i have seen the rather limited info for this case with triathlon femoral component and liner exchange due to instability some 3-years post implantation.The tibial component was apparently retained.What exactly has caused failure in this case, the balance between patient-related and procedure-related factors cannot be substantiated in this case due to lack of proper information.More specific radiological information including clinical examination findings and/or retrieval analysis may all help further to solve this case although this case would certainly not be associated with device-related factors.Device history review: not performed as lot information was not provided.Complaint history review: not performed as lot information was not provided.Conclusions: revision surgery took place due to instability whereby the reported cr femoral and cs insert components were replaced with ps femoral and insert components.The exact cause of the event could not be determined as insufficient information was provided.Further information such as product lot codes, device return, x-rays as well as patient history and follow-up notes are needed to complete the investigation for determining a root cause.A capa trend analysis was conducted for the reported failure mode and concluded instability may result from other factors not necessarily related to the device.No further investigation is possible at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Unstable total knee converted knee to a posterior stabilized construct.
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