STRYKER ORTHOPAEDICS-MAHWAH X3 TRIATHLON CS INSERT NO 3 9MM; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5531-G-309-E |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 03/04/2024 |
Event Type
Injury
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Event Description
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It was reported that the patient's right knee was revised due to infection.A 3x9 cs insert was exchanged for another 3x9 cs insert.Rep confirmed that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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The following devices were also listed in this report: triathlon p/a cr beaded #3l; cat# 5517f302; lot# unknown unknown triathlon baseplate; cat# unknown; lot# unknown tritanium patella-asymmetric; cat# 5552-l-299; lot# ujr61 it cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.Reported event: an event regarding infection involving a triathlon insert was reported.The event was not confirmed.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: no medical records were received for review with a clinical consultant.-product history review: could not be performed as the device lot details were not provided.-complaint history review: could not be performed as the device lot details were not provided.Conclusions: it was reported that the patient was revised due to infection.All stryker products sold as sterile are validated to a minimum sterility assurance level sal of 10^-6 in accordance with applicable iso standards.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, pre- and post-operative x-rays and the revision operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and/or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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