This pi is for patient 10 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.
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Reported event an event regarding pain/ complications involving an unknown mako was reported.The event was not confirmed.Method & results product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: it was reported complications with ten mako primary procedure patients were noticed; this pi is for patient 10 of 10.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.Details of the complications for this specific patient were not reported.The nature of intervention for this specific patient is unknown.The exact cause of the event could not be determined because insufficient information was provided.Further information such as device details, return of the device, pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.H3 other text : device not returned.
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This pi is for patient 10 of 10.Surgeon reported he is experiencing a high complication rate with patients whose primary procedures were mako procedures.The nature of the 10 cases is unknown at the time of report.Complications reported include effusions, pain, stiffness, possibly requiring 'scopes' and/ or poly exchanges.The nature of intervention for each of the 10 patients is unknown.
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