This pi is for the robot used in the primary surgery.Information received from sales rep on (b)(6) 2019: upon review by joint replacement research for surgeon's milestone payment, patients were noted to have had their implant knee removed, revised, or re-operated on as reported.Reporter has indicated she does not have access to any additional information as the reporting site takes on all regulatory responsibilities, and all data is de-identified.This pi is for patient 3 of 23, revised due to pain, robot used in primary.The patient was revised from pka to tka approximately after 1 year of implantation.Pka.
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Reported event: an event regarding revision involving 3.0 rio robotic arm - mics, catalog: 209999 was reported.Method & results: -device history review: product history review could not be performed because robot serial number was not received.-complaint history: based on the device identification (pn 209999) the complaint databases were reviewed from 2011 to present for similar reported events regarding a revision from a partial knee procedure to a total knee procedure due to pain.There were 31 other reported events ( pr 1623865, pr 1623940, pr1638056, pr1691636, pr1728493, pr1893969, pr1915354, pr1915371, pr1928578, pr1921712, pr1956944, pr1968316, pr1968467, pr2006964, pr2006955, pr2008331, pr2006947, pr2007174, pr2006959, pr2006962, pr2006963, pr2005454, pr2008328, pr2008330, pr2008333, pr2008335, pr2008339, pr2008342, pr2008343, pr2008344, and pr2008346).-conclusion: product inspection could not be performed because session files and logs were not available due to all data de-identified.
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This pi is for the robot used in the primary surgery.Information received from sales rep on (b)(6) 2019: upon review by joint replacement research for surgeon's milestone payment, patients were noted to have had their implant knee removed, revised, or re-operated on as reported in the table attached.Reporter has indicated she does not have access to any additional information as the reporting site takes on all regulatory responsibilities, and all data is de-identified.This pi is for patient 3 of 23, revised due to pain, robot used in primary.The patient was revised from pka to tka approximately after 1 year of implantation.Pka.
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