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Catalog Number 209999 |
Device Problems
Computer Software Problem (1112); Non Reproducible Results (4029)
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Patient Problem
Discomfort (2330)
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Event Date 03/04/2019 |
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 surgery.It was reported that the patient's left hip was revised due to the shell shifting and becoming anteverted.Surgeon confirmed shifting by comparing post-op x-rays from primary implant on (b)(6) 2019 and post-op x-rays in late (b)(6) 2019.Possible cause or contributor to shell shifting was not reported to rep.A shell, 2 screws, liner, biolox ceramic head and accolade ii stem were revised to a trident tritanium revision shell with 5 screws, an adm/mdm liner construct, lfit v40 metal head, and accolade ii stem.There are no allegations against the liner, head, or stem.Rep provided primary and revision implant sheets and reported no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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Follow-up #1 and final report submitted to update sections d.3, g.1, g.4, g.7, h.2, h.3, h.6, h.10 and h.11 based on the results of investigation.Reported event: an event regarding revision involving 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 ((b)(4)) the complaint databases were reviewed from 2011 to present for similar reported events regarding revision.There were 8 other reported event for the listed catalog number ((b)(4)).-conclusion: product inspection could not be completed due to no logs or session files being released by the hospital or surgeon.H3 other text : evaluation could not be performed because the logs/session files were not provided.
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Event Description
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This pi is for the robot used in the primary surgery.It was reported that the patient's left hip was revised due to the shell shifting and becoming anteverted.Surgeon confirmed shifting by comparing post-op x-rays from primary implant on (b)(6), 2019 and post-op x-rays in late (b)(6) of 2019.Possible cause or contributor to shell shifting was not reported to rep.A shell, 2 screws, liner, biolox ceramic head and accolade ii stem were revised to a trident tritanium revision shell with 5 screws, an adm/mdm liner construct, lfit v40 metal head, and accolade ii stem.There are no allegations against the liner, head, or stem.Rep provided primary and revision implant sheets and reported no further information will be released by the hospital or surgeon.
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Search Alerts/Recalls
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