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Catalog Number 209999 |
Device Problems
Loss of or Failure to Bond (1068); Output Problem (3005)
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Patient Problems
Tissue Damage (2104); No Known Impact Or Consequence To Patient (2692)
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Event Date 11/14/2018 |
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 for navigation in the primary procedure.It was reported that patient's left hip was revised due a periprosthetic femoral fracture and stem subsidence after patient fell.The securfit advanced stem, biolox 32 +0 head, and 32mm 0° c liner were revised to a competitor modular stem construct and femoral head with a stryker adm/mdm liner construct and 4 cable and sleeve sets.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
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Manufacturer Narrative
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Reported event: an event regarding revision due to loosened implant 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 (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding revision.There were 6 other reported event for the listed catalog number (pr1442085, pr1737869, pr1898251, pr1930169, pr1950907, and pr1962866).-conclusion: product inspection could not be completed due to no logs or session files not being available from hospital or surgeon.
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Event Description
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This pi is for the robot used for navigation in the primary procedure.It was reported that patient's left hip was revised due a periprosthetic femoral fracture and stem subsidence after patient fell.The securfit advanced stem, biolox 32 +0 head, and 32mm 0° c liner were revised to a competitor modular stem construct and femoral head with a stryker adm/mdm liner construct and 4 cable and sleeve sets.Rep reported that x-rays, medical records, and additional information are not available due to hospital policy.
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Search Alerts/Recalls
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