STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TRIATHLON CR KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, C
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Catalog Number UNK_JR |
Device Problem
Unstable (1667)
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Patient Problem
Joint Laxity (4526)
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Event Date 08/31/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding instability involving an unknown triathlon knee 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 instability.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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Event Description
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As reported: "right knee revised due to instability.The only operative information the patient was able to provide the facility that it was a triathlon knee done in 2007 from another facility.All components were explanted and revised to triathlon ts.Surgeon and facility had no further information on this patient's cr implant construct.".
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