Catalog Number 209999 |
Device Problems
Computer Software Problem (1112); Output Problem (3005)
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Patient Problem
Discomfort (2330)
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Event Date 03/27/2019 |
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.Patient called stating he had a right knee replacement done on (b)(6) 2018 and was revised on (b)(6) 2019 due to instability.Patient stated his surgery was done robotically, and would like to know if the robot was involved in a recall.
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Manufacturer Narrative
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Reported event: an event regarding revision surgery due to implant instability following a total knee procedure involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: device history review: a review of the dhr associated with rio 590 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 surgery due to instability following a tka procedure.There were other reported events for the listed catalog number ((b)(4)).Conclusion: combined rotatory malposition of femoral and tibial component has contributed to instability in this patient¿s triathlon knee arthroplasty requiring revision surgery.Part of the problem may be explained by unknown issues encountered during instrumentation while using robotic assistance for the procedure but there is no information available to further detail these aspects.Does the review identify any procedural related factors that contributed to the event? - combined rotatory malposition of femoral and tibial component possibly as a consequence to error in use of the mako robot does the review identify any patient related factors that contributed to the event? - none does the review identify any device related factors that caused or contributed to the adverse event? - no device-related factors are associated with any of the implanted devices.
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Event Description
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This pi is for the robot.Patient called stating he had a right knee replacement done on (b)(6) 2018 and was revised on (b)(6) 2019 due to instability.Patient stated his surgery was done robotically, and would like to know if the robot was involved in a recall.
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Search Alerts/Recalls
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