STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PS X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5532-G-413 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Injury (2348)
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Event Date 11/25/2015 |
Event Type
Injury
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Manufacturer Narrative
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The following other devices were also listed in this report: tri cemented stem 12mmx50mm; cat# 5560-s-112; lot# 0036905i.Tri lm/rl tib aug sz4 5mm; cat# 5545-a-401; lot# fuhha.Tri rm/ll tib aug sz4 5mm; cat# 5545-a-402; lot# er9km7e.Triathlon symmetric x3 patella; cat# 5550-g-319; lot# kp9t.Tri ts baseplate size 4; cat# 5521-b-400; lot# tbv3a.Triathlon ps fem component, cemented; cat# 5515-f-401; lot# mrrrsw3a.It cannot be determined which, if any of these devices may have caused or contributed to the patient's infection.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.
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Event Description
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Due to infection dr swapped poly and irrigated left knee.
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Manufacturer Narrative
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An event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method and results: device evaluation and results: could not be performed as no items associated with the event were returned or made available for evaluation.Medical records received and evaluation: insufficient medical records were received for review with a clinical consultant.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 and the sterile lot.Conclusions: the source of the infection could not be determined as patient information, clinical history, and results of blood work for infection were not provided.A capa trend analysis was conducted for the reported failure mode and concluded infection is most likely a result from other factors not necessarily related to the device in the healthcare facility setting.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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Event Description
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Due to infection doctor swapped poly and irrigated left knee.
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