STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN_TRIATHLON PKR KNEES (3); PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 02/19/2024 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding revision involving an unknown triathlon knee was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.H3 other text: device not returned to the manufacturer.
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Event Description
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"this report is for 3 unknown triathlon pkr knees revisions documented in the swiss national hip & knee joint registry (siris) annual report 2023".
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Search Alerts/Recalls
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