STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN PATELLAR COMPONENT; 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
Bone Fracture(s) (1870)
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Event Date 03/06/2024 |
Event Type
Injury
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Manufacturer Narrative
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Reported event: an event regarding periprosthetic fractur involving an unknown patella 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 periprosthetic fracture.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device-identifying information such as catalog numbers and lot codes, 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.
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Event Description
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As reported via medwatch mw5151715: it was reported that the patella fractured, surgeon explanted component revising tibial insert while in capsule.Patella explanted was a stryker product.
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Search Alerts/Recalls
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