STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON INSERT CR#8 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5530G809 |
Device Problems
Unstable (1667); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Injury (2348); Tissue Breakdown (2681)
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Event Date 11/19/2015 |
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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Left knee revision due to soft tissue pain and instability.Patient had open synovectomy.Surgeon removed poly for a different poly cs vs.Cr, explanted a size 9 and implanted a size 13.Procedure completed successfully with no delays.
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Manufacturer Narrative
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An event regarding revision due to instability involving a triathlon insert was reported.The event was not confirmed.Method & results: -device evaluation and results: not performed as product was not returned.-medical records received and evaluation: not performed as no medical records were provided.-device history review: the device was manufactured and accepted into final stock with no reported discrepancies.-complaint history review: there have been no other similar reported events for the lot referenced.Conclusions: revision surgery took place due to soft tissue pain and instability whereby the reported 9mm cr insert component was explanted and replaced with 13mm cs insert component.The exact cause of the event could not be determined as insufficient information was provided.Further information such as device return, pre- and post-operative x-rays and operative reports 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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Left knee revision due to soft tissue pain and instability.Patient had open synovectomy.Surgeon removed poly for a different poly cs vs.Cr, explanted a size 9 and implanted a size 13.Procedure completed successfully with no delays.
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