MAKO SURGICAL CORP. MCK TIBIAL ONLAY INSERT-SZ 5-8MM; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180705-1 |
Device Problems
Loss of Osseointegration (2408); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Discomfort (2330)
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Event Date 09/19/2013 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer due to hospital policy.Additional information has been requested.Should additional information become available at the later time it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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Tibial loosening with mechanical failure, left uka.Revision of tibial compartment.
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Manufacturer Narrative
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An event regarding loosening involving an mako insert was reported.Conclusion: there is no indication that the product reported in this investigation contributed to the event since patient was revised due to tibial component loosening.The insert is an integral part of the tibial component construct and will have to be explanted together with the loose baseplate and no other allegations were made against the insert.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Tibial loosening with mechanical failure, left uka.Revision of tibial compartment.
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Search Alerts/Recalls
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