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 Problems
Pain (1994); Loss of Range of Motion (2032)
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Event Date 10/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: 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.H3 other text : device not returned to the manufacturer.
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Event Description
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It was reported through stryker facebook page: "had mine done 2 1/2 years ago, made mine worse, lost almost all range of motion,and in constant pain.Just saw the 10th different doctor today, only way to make better is to remove and start over.
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Search Alerts/Recalls
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