Catalog Number 209999 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Discomfort (2330); No Known Impact Or Consequence To Patient (2692)
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Event Date 02/01/2017 |
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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The surgeon revised a patient.They had a mako hip done on (b)(6) 2014 due to dislocation.He removed the liner and cemented a stryker x3 insert into the existing shell.He repaired the soft tissue/ligaments as well.
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Manufacturer Narrative
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Reported event: an event regarding a total hip revision, involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method and results: device history: not performed as the device being inspected is software.Rio serial number not reported.Complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding hip revision.There was only 1 other reported events (b)(4).Conclusion: device inspection could not be performed, no session data was provided.Per the mps "we no longer have access to the session files, as the hard drives were removed." not returned to manufacturer.
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Event Description
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The surgeon revised a patient the had a mako hip done on (b)(6) 2014 due to dislocation.He removed the liner and cemented a stryker x3 insert into the existing shell.He repaired the soft tissue/ligaments as well.
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Search Alerts/Recalls
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