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 due to infection at tibial baseplate site during 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 269 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 infection at the baseplate.There were no other similar reported events for the listed catalog number.-conclusion: product inspection could not be completed because log files and session files could not be provided by the mps.Evaluation could not be performed because the logs/session files were not provided.
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