STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN MRH FEMORAL COMPONENT; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_LIM |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 03/13/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient's right knee was revised due to femoral component loosening.A cemented stemmed mrh femoral component plus bushings, sleeve, bumper and rotating component were revised to gmrs and mrh components with a triathlon cone augment and cables.
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Manufacturer Narrative
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An event regarding loosening involving an unknown mrh femoral component 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 loosening of the stemmed femoral component.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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