Reported event: an event regarding inaccurate resection involving 3.0 rio® robotic arm - mics, catalog: 209999 was reported.It was reported, ¿revision arthroplasty total knee left total knee poly versus full revision.Pre-op diagnosis: stiffness of left knee.Surgeon commented there is a flexion contracture so he downsized poly to 12mm cs.No further information available per hospital¿.Product evaluation and results: not performed as case session data was not provided.Product history review.Review of the device history records associated with rio 234 indicate quality inspection procedures were completed with no reported discrepancies.Complaint history review.A search of the complaint database under device identification pn 209999 reports similar complaints for tka software - inaccurate resection.The complaint record numbers are: (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4), (b)(4).Conclusions: the failure could not be determined as no case session data or logs were provided after three communication attempts were made.Without the case files the operation set up, bone registration, bone preparation and implant selection could not be assessed.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 - inaccurate resection.
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