STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN KNEE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Swelling/ Edema (4577)
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Event Date 03/08/2024 |
Event Type
Injury
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Event Description
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It was reported on the stryker facebook page, "i let myself get talked into doing both at the same time.Had trouble with swelling for three years afterward, still do occasionally.All surgeon would do is pat himself on the back and talk about how good they looked on the x-rays!" this pi is for the left knee.
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Manufacturer Narrative
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Reported event: an event regarding patient factors involving an unknown knee 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 remains implanted.-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: 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 and the 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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Search Alerts/Recalls
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