Catalog Number UNK_OFL |
Device Problem
Insufficient Information (3190)
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Patient Problem
Pain (1994)
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Event Date 07/20/2020 |
Event Type
Injury
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Manufacturer Narrative
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As part of normal complaint follow-up, an evaluation of the event has been initiated by mako surgical.A supplemental report will be submitted when additional information becomes available.Device not returned.
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Event Description
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This pi is for patient 7 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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Manufacturer Narrative
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Reported event: an event regarding pain involving an unknown mako implant was reported.The event was not confirmed.Method & results: device evaluation and results: not performed as product was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: could not be performed as lot code information was not provided.Complaint history review: could not be performed as lot code information was not provided.Conclusion: the exact cause of the event could not be determined because insufficient information was provided.Additional information including device details, operative reports, progress notes, x-rays and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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Event Description
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This pi is for patient 7 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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Search Alerts/Recalls
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