STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN SIZE 4 TIBIAL BASEPLATE; PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, SEMI-CONSTRAINED, UNCEMENTED, POROUS, CO
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Catalog Number UNK_JR |
Device Problem
Osseointegration Problem (3003)
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Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
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Event Date 08/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding revision for unspecified reason involving an unknown baseplate 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.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: it was reported that the patient's left knee was revised due to loosening of the femoral component.It was not reported that why the patient's tibial baseplate component was revised.The exact cause of the event could not be determined because insufficient information was provided.Further information such as reason for the baseplate component revision, product identification, return of the device, pathology reports, pre- and post-operative x-rays and the primary 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 loosening of the femoral component.The patient's size 5 cr femur, 4x13 cs insert, and size 4 tibial baseplate were revised to another stryker knee.There are no allegations against the insert.Rep reported that no further information is available.
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Search Alerts/Recalls
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