STRYKER ORTHOPAEDICS-MAHWAH TRIATHLON CR X3 TIBIAL INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number 5530-G-609 |
Device Problem
Unstable (1667)
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Patient Problems
Injury (2348); Joint Laxity (4526)
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Event Date 06/29/2020 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Revision of triathlon knee due to instability when patient stands from seated position.Surgeon states that patient was stable post initial surgery but became unstable post operative lay as they were very active.Cr femur and insert currently in situ, only liner removed and replaced as per photos.Full stability achieved according to surgeon.Original surgery date (b)(6) 2019.
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Manufacturer Narrative
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Reported event: an event regarding instability 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.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: a review of the device manufacturing records indicate that all devices accepted into final stock were free from discrepancies.Complaint history review: there have been no other similar events for the lot referenced.Conclusions: 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 primary 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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Revision of triathlon knee due to instability when patient stands from seated position.Surgeon states that patient was stable post initial surgery but became unstable post operative lay as they were very active.Cr femur and insert currently in situ, only liner removed and replaced as per photos.Full stability achieved according to surgeon.Original surgery date (b)(6)2019.
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