MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 6-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180706-1 |
Device Problems
Mechanical Problem (1384); Difficult To Position (1467); 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 01/12/2016 |
Event Type
malfunction
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Manufacturer Narrative
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When completed, the investigation results will be submitted in a supplemental report.
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Event Description
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The issue occurred when inserting our 6x8 poly.The poly would not seat on the posterior aspect of the baseplate.Before opening the poly, i confirmed 3x to the circulator, scrub and surgeon that all sizes were correct.We opened the second 6x8 poly and it went right in without any issue.There was no harm to the patient.
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Manufacturer Narrative
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An event regarding damaged insert due to seating issue involving a mck tibial onlay insert-sz 6-8mm was reported.The event was confirmed.Method & results: device evaluation: visual inspection confirmed the insert was damaged due to implantation.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies complaint history review: there have been no other events for the lot referenced.Conclusion: the investigation confirmed that the device was damaged during attempt at implantation.There is no indication at this time that the design, materials, or manufacturing of the subject device contributed to the event.If additional information becomes available, this investigation will be reopened.
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Event Description
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The issue occurred when inserting our 6x8 poly.The poly would not seat on the posterior aspect of the baseplate.Before opening the poly, i confirmed 3x to the circulator, scrub and surgeon that all sizes were correct.We opened the second 6x8 poly and it went right in without any issue.There was no harm to the patient.
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Search Alerts/Recalls
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