STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON P/A CR BEADED #3R; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Model Number 5517-F-302 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problems
Pain (1994); Inadequate Osseointegration (2646)
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Event Date 05/15/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding loosening involving a triathlon femoral component 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 that the patient was revised d due to loosening of the femoral component.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.As reported: "the revision was due to pain from a loose femur.It was suspected from x-ray that the femur was loose.It was discovered during surgery that the femur did not in-grow and was in fact loose.The use of mako in the primary knee was not thought to have anything to do with the loose femur.There was no evident reason for the loose femur.No further information is available from the hospital or surgeon." a femoral component and insert were revised to a femoral component with stem and augments and a new insert.
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Search Alerts/Recalls
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