Catalog Number 209999 |
Device Problems
Computer Software Problem (1112); Non Reproducible Results (4029)
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Patient Problem
Bone Fracture(s) (1870)
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Event Date 05/21/2019 |
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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This pi is for the robot used in the primary procedure.As reported on pi (b)(6): "[surgeon] revised a left mako hip originally done on (b)(6) 2019 due to femoral fracture and stem subsidence.He replaced the stem, head and sleeve with a new accolade ii stem, head and sleeve and cables".Rep provided usage sheets for primary and revision surgeries and reported that no further information is available due to hospital policy.
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Manufacturer Narrative
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Reported event: an event regarding revision involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 118 found quality inspection procedures 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 revision.There were 9 other reported event for the listed catalog number (b)(4).Conclusion: product inspection could not be completed due to no further information is available due to hospital policy.
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Event Description
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This pi is for the robot used in the primary procedure.As reported on (b)(4): "[surgeon] revised a left mako hip originally done on (b)(6) 2019 due to femoral fracture and stem subsidence.He replaced the stem, head and sleeve with a new accolade ii stem, head and sleeve and cables".Rep provided usage sheets for primary and revision surgeries and reported that no further information is available due to hospital policy.
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Search Alerts/Recalls
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