MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 2; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Model Number 180602 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 11/25/2019 |
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.Device not returned.
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Event Description
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It was reported by the patient's attorney through a legal claim that allegedly on (b)(6) 2016 the patient underwent a left knee medial compartment makoplasty and during that procedure simplex hv bone cement with gentamicin was utilized to cement all components.It is further alleged that on (b)(6) 2019 the patient underwent revision surgery due to loosening of her tibial component.
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Event Description
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It was reported by the patient's attorney through a legal claim that allegedly on (b)(6) 2016 the patient underwent a left knee medial compartment makoplasty and during that procedure simplex hv bone cement with gentamicin was utilized to cement all components.It is further alleged that on (b)(6) 2019 the patient underwent revision surgery due to loosening of her tibial component.
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Manufacturer Narrative
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Reported event an event regarding loosening 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: all devices were manufactured and accepted into final stock with no relevant reported discrepancies. -complaint history review: there have been no other similar events for the lot referenced.Conclusions: 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.H3 other text : device not returned.
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