STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON 4X11 TS INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Unstable (1667)
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Patient Problems
Hyperextension (4523); Joint Laxity (4526)
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Event Date 07/17/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding instability involving an unknown 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.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, pathology reports, pre- and post-operative x-rays 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.The following devices were also listed in this report: device name#triathlon size 4 right ts femur; cat#unknown ; lot#unknown device name#triathlon size 4 universal baseplate; cat#unknown ; lot#unknown.It cannot be determined which, if any of these devices may have caused or contributed to the patient's experience.
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Event Description
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It was reported that the patient's left knee was revised due to instability (surgeon indicated that joint laxity was leading to hyperflexion).A triathlon knee was revised to a hinge knee construct.
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Search Alerts/Recalls
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