Catalog Number 209999 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problems
Arthritis (1723); Pain (1994); Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/10/2017 |
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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Partial lateral menisectomy.Scheduled for revision to tka on (b)(6) 2016 due to progression of arthritis in the lateral compartment of the left knee.
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Manufacturer Narrative
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Reported event: an event regarding a pka revision involving a 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: not performed as the device being inspected is software.Rio serial number not reported.Complaint history: based on the device identification (pn (b)(4)) the complaint databases were reviewed from 2011 to present for similar reported events regarding patient revision from pka to tka.There were five other reported events for the listed catalog number.((b)(4)) conclusion: device inspection could not be performed, no session data was provided.Device not returned.
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Event Description
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Partial lateral menisectomy.Scheduled for revision to tka on (b)(6) 2016 due to progression of arthritis in the lateral compartment of the left knee.
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Search Alerts/Recalls
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