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 12/29/2022 |
Event Type
Injury
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Event Description
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Revised a right mako lateral uni knee due to tibial loosening.No allegations made against the implants.
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Manufacturer Narrative
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It was noted that the device is not available for evaluation.Should additional information become available, it will be provided in a supplemental report upon completion of the investigation.
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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: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant .Device history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.Complaint history review: there has been 1 other similar events for the lot referenced.Conclusion: the event could not be determined because insufficient information was provided.Further information such as return of the device, pre- and post-operative x-rays, 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 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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Revised a right mako lateral uni knee due to tibial loosening.No allegations made against the implants.
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Search Alerts/Recalls
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