STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN KNEE; 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 Problem
Loss of Range of Motion (2032)
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Event Date 01/09/2024 |
Event Type
Injury
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Event Description
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It was reported through the stryker facebook page, "had it done a month ago and not happy can't bend it much".
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Manufacturer Narrative
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An event regarding range of motion (rom) 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 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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Search Alerts/Recalls
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