MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180613 |
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 09/29/2023 |
Event Type
Injury
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Manufacturer Narrative
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As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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During insertion of mck tibial baseplate, the proximal medial side of the tibia was fractured.Manual tka was performed.
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Manufacturer Narrative
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Reported event: an event regarding intraop fracture involving a mako 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.-clinician review: no medical records were received for review with a clinical consultant.-product history review: review of the device history record could not be performed as the device lot details were not provided.-complaint history review: complaint history review could not be performed as the device lot details were not provided.Conclusions: it was reported that during procedure the patient suffered a tibia bone fracture.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 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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During insertion of mck tibial baseplate, the proximal medial side of the tibia was fractured.Manual tka was performed.
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Search Alerts/Recalls
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