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
Insufficient Information (3190)
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Patient Problem
Injury (2348)
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Event Date 07/25/2017 |
Event Type
Injury
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Additional information has been requested.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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Event Description
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Physician revised a medial mako knee to a primary cr triathlon total knee with a 5mm tibial augment due to disease progression.
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Manufacturer Narrative
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An event regarding revision due to patient factors (disease progression) involving a mako baseplate was reported.The event was not confirmed.A visual, functional and dimensional inspection could not be performed as the device was not returned.The provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.Further information such as revision operative report & dated serial x-rays are needed for completion of the assesment.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.There has been no other event for the lot referenced.It was reported that patient was revised due to disease progression.The event could not be confirmed nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.The provided medical information was submitted to a consulting clinician who deemed it insufficient for a medical review.No further investigation for this event is possible at this time.Further information such as return of the device, revision operative report & dated serial x-rays are needed to investigate this event further.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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Event Description
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Physician revised a medial mako knee to a primary cr triathlon total knee with a 5mm tibial augment due to disease progression.
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Search Alerts/Recalls
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