MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 1-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
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Catalog Number 180701-1 |
Device Problems
Fitting Problem (2183); Positioning Problem (3009)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/06/2019 |
Event Type
malfunction
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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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Event Description
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The inner surface and edge of insert is not smooth, so it did not match with the baseplate pocket during the operation.The surgeon requested for same-sized, so same catalog number but different lot number insert was used.The new insert was fully seated on the baseplate without any problem.
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Event Description
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The inner surface and edge of insert is not smooth, so it did not match with the baseplate pocket during the operation.The surgeon requested for same-sized, so same catalog number but different lot number insert was used.The new insert was fully seated on the baseplate without any problem.
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Manufacturer Narrative
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An event regarding assembly issue involving a mako inserter was reported.The event was not confirmed.Method & results: device evaluation and results: visual inspection was performed as part of the material evaluation and indicated the following comments: material analysis: damage observed on the insert consistent with contact against a hard object and attempted implantation and explantation.Based on the given information, no identifiable materials or manufacturing discrepancies were observed on the surfaces examined.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device 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 reported lot.Conclusions: the event could not be confirmed nor could the root cause be determined because the insufficient medical information was provided.Further information such as patient history, histopathology report & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.
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