MAKO SURGICAL CORP. TIBIAL INLAY IMPACTOR HEAD; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 160177 |
Device Problems
Break (1069); Fracture (1260)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Additional information has been requested.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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The piece broke while impacting the baseplate.
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Manufacturer Narrative
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Reported event: an event regarding crack/fracture involving a mako impactor was reported.The event was not confirmed.Method & results: -device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.-medical records received and evaluation: not performed as patient factors did not contribute to the event.-device history review: a review of the device history records could not be performed as no lot information was provided.-complaint history review: a complaint history review could not be performed as no lot information was provided.Conclusions: the event could not be confirmed nor the root cause determined because insufficient information was provided.Further information such as return of device, patient history & follow-up notes are needed to investigate this event further.If additional information and/or device becomes available, this investigation will be reopened.Not returned to the manufacturer.
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Event Description
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The piece broke while impacting the baseplate.
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Search Alerts/Recalls
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