STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN TRIATHLON 5X9 CR/ CS INSERT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Mechanical Problem (1384)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Date 09/13/2023 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding range of motion (rom) 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 pain and slight hyper-extension.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 left knee was revised due to anterior pain and slight hyper-extension.Surgeon resurfaced the patient's native patella and revised a 5x9 cr/ cs insert to a 5x12 cs insert.When implanting the new insert, the insert would not lock into the baseplate.The cause was determined to be soft tissue being in the way.The insert was wasted, tissue was addressed, and a new insert was implanted.
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