Catalog Number 209999 |
Device Problem
Insufficient Information (3190)
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Patient Problem
Discomfort (2330)
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Event Date 07/12/2017 |
Event Type
Injury
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Manufacturer Narrative
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As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.
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Event Description
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Revision of mako uni knee due to mispositioned tibial implant.Post case x-ray and patient not happy.
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Manufacturer Narrative
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Reported event: the reported device is a 3.0 rio® robotic arm - mics, catalog: 209999.Device history review: a review of the dhr associated with rio 373 found quality inspection procedures and pt review successfully passed.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding a revision from a partial knee procedure to a total knee procedure.There were other reported events ((b)(4)).Conclusion: no investigation was conducted since no information was provided.The device was not returned for evaluation.
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Event Description
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Revision of mako uni knee due to mis-positioned tibial implant.Post case x-ray and patient not happy.
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Search Alerts/Recalls
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