STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON PRIM TIB BASEPLATE - CEMENTED; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5520-B-300 |
Device Problem
Unintended Movement (3026)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 04/25/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding periprosthetic fracture and subsidence involving a triathlon baseplate 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: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to tibial fracture and baseplate subsidence.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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It was reported that the patient's right knee was revised after patient complaint of pain following 2 falls.Pre-operatively, surgeon reported tibial fracture and baseplate subsidence.The baseplate, insert, and femoral component were revised.Rep confirmed femur was revised to convert to a ps knee, and that there were no allegations against the revised insert.The patellar component was retained.Rep confirmed that no further information will be released by the hospital or surgeon.
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