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 inaccurate cup placement involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: -device history review: a review of the dhr associated with rio 299 found quality inspection procedures successfully passed.-complaint history: based on the device identification (b)(4)the complaint databases were reviewed from 2011 to present for similar reported events regarding cup placement discrepancy.There were 19 other reported events (b)(4).-conclusion: a view of the this case session data confirmed that the application shows that the cup was 5+ mm proud.Both the impaction depth reading shows the cup was 5.6mm proud and the impacted cup cor value shows the cup was 5.47mm from the planned cup center.The session logs shows that registration and ct landmark selections were accurately done and inaccuracies in the plan were minimal.Movement of an array could account for the discrepancy the doctor felt with cup placement as compared to where the application showed, but cannot be confirmed.It¿s also possible the cup was not fully seated and the cup fit was tight.The session data does not show the application had any unintended behavior.
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