Model Number 209999 |
Device Problems
Computer Software Problem (1112); Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 08/18/2019 |
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 procedure.As reported in pi # (b)(4): "dr.Performed an i&d with a tibial insert exchange of a mako left medial uni knee due to infection.Original surgery was (b)(6) 2019".Rep provided primary and revision usage sheets and reported that no further information is available from the hospital or surgeon.
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Event Description
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This pi is for the robot used in the primary procedure.As reported in pi # (b)(4): "dr.Performed an i&d with a tibial insert exchange of a mako left medial uni knee due to infection.Original surgery was (b)(6)2019".Rep provided primary and revision usage sheets and reported that no further information is available from the hospital or surgeon.
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Manufacturer Narrative
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Reported event: an event regarding infection involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.As reported in pi # (b)(4): "dr.Performed an i&d with a tibial insert exchange of a mako left medial uni knee due to infection.Original surgery was (b)(6)2019 ".Rep provided primary and revision usage sheets and reported that no further information is available from the hospital or surgeon.Product evaluation and results: not performed as case session data was not provided.Product history review review of the device history records was not completed as the robot number was not provided.Complaint history review a search of the complaint database under device identification pn 209999 reports no similar complaints for tka software - other.Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.No additional investigation or specific actions are required at this time.If additional information is received such as the session files, then the complaint will be reopened.Corrective action/preventive action: a search of the nc/capa database under device identification pn 209999 reports no records related to tka software - other.H3 other text : device not returned.
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Search Alerts/Recalls
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