Model Number 209999 |
Device Problems
Osseointegration Problem (3003); Positioning Problem (3009); Insufficient Information (3190)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 02/26/2020 |
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.
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Event Description
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It was reported that the patient's left knee was revised due to loosening (it was not reported to the rep which device(s) experienced loosening.No possible cause or contributor for loosening was reported to the rep).The patient's mako pka was revised to a total cr knee.Rep provided explant pictures, primary and revision usage sheets, and reported that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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Reported event.An event regarding inaccurate resection involving a mako pka software was reported.The event was not confirmed.Method & results.Review of the log/session files has not been completed within 90days of the complaint being opened.The complaint will be closed with an associated risk assessment.Additional failures will be assessed once the log/session file review has been completed.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that rob281 was inspected on 15/05/2014 and the quality inspection procedures were completed with no reported discrepancies -complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: rob281 shows 0 similar complaints for pka software - inaccurate resection.Conclusions: the exact cause of the event could not be determined because insufficient information was made available for evaluation.Review of the log/session files has not been completed within 90days of the complaint being opened.A review of the case session/log data is needed to complete a full investigation for determining root cause.In addition to a review of the log/session, a field service engineer conducts scheduled maintenance on the robot to ensure the robot is system ready.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Device not returned.
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Event Description
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It was reported that the patient's left knee was revised due to loosening (it was not reported to the rep which device(s) experienced loosening.No possible cause or contributor for loosening was reported to the rep).The patient's mako pka was revised to a total cr knee.Rep provided explant pictures, primary and revision usage sheets, and reported that no further information will be released by the hospital or surgeon.
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Manufacturer Narrative
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An event regarding inaccurate resection involving a mako pka software was reported.The event was not confirmed.Method & results: a review of the log/session files found the following: there were no indications of system failure based on the logs provided.The registration error of the femur was high at.4755 compared to the tibia at.2457011.This higher registration error can lead to some error in cutting.There were no signs of trackers being bumped and the warnings identified in section 11 would not lead to accuracy issues.Based on the logs received the system behaved as expected.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records shows that (b)(6) was inspected and the quality inspection procedures were completed with no reported discrepancies complaint history review: a review of complaints in trackwise related to p/n 209999, robot number: (b)(6) shows 0 similar complaints for pka software - inaccurate resection.Conclusions: the failure was reviewed through return of the provided log/session files.The data at this time shows that all system verification values were within the accuracy tolerance region; no system defect or malfunction is suspected.No additional investigation or specific actions are required at this time.If additional information such as including operative reports, progress notes and x-rays are received, then the complaint will be reopened.System is ready for use.
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Event Description
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It was reported that the patient's left knee was revised due to loosening (it was not reported to the rep which device(s) experienced loosening.No possible cause or contributor for loosening was reported to the rep).The patient's mako pka was revised to a total cr knee.Rep provided explant pictures, primary and revision usage sheets, and reported that no further information will be released by the hospital or surgeon.
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Search Alerts/Recalls
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