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Catalog Number 209999 |
Device Problems
Computer Software Problem (1112); Non Reproducible Results (4029)
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Patient Problems
Pain (1994); No Known Impact Or Consequence To Patient (2692)
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Event Date 01/24/2019 |
Event Type
Injury
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Manufacturer Narrative
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As part of the 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 surgery.Information received from sales rep on (b)(6) 2019: upon review by joint replacement research for surgeon's milestone payment, patients were noted to have had their implant knee removed, revised, or re-operated on as reported in the table attached.Reporter has indicated she does not have access to any additional information as the reporting site takes on all regulatory responsibilities, and all data is de-identified.This pi is for patient 15 of 23, revised due to cause unknown, robot used in primary.The patient was revised from pka to tka approximately after 8 years and 5 months of implantation.Pka.
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Event Description
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This pi is for the robot used in the primary surgery.Information received from sales rep on (b)(6) 2019: upon review by joint replacement research for surgeon's milestone payment, patients were noted to have had their implant knee removed, revised, or re-operated on as reported in the table attached.Reporter has indicated she does not have access to any additional information as the reporting site takes on all regulatory responsibilities, and all data is de-identified.This pi is for patient 15 of 23, revised due to cause unknown, robot used in primary.The patient was revised from pka to tka approximately after 8 years and 5 months of implantation.Pka.
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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: product history review could not be performed because robot serial number was not received.-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 due to pain.There were 15 other reported events ((b)(4)).-conclusion: product inspection could not be performed because session files and logs were not available due to all data de-identified.
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Search Alerts/Recalls
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