Catalog Number UNK_OFL |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Unspecified Infection (1930)
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Event Date 01/27/2021 |
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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It was reported that a stage 1 revision on a right mako knee implanted (b)(6) 2020 was performed due to a staph infection.All components were removed and implants used as a spacer were placed.Rep provided primary and revision usage and a picture of the explants, and confirmed that no further information will be released by the hospital or surgeon.
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Event Description
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It was reported that a stage 1 revision on a right mako knee implanted on (b)(6) 2020 was performed due to a staph infection.All components were removed and implants used as a spacer were placed.Rep provided primary and revision usage and a picture of the explants, and confirmed 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 infection involving an unknown mako robot/tka software was reported.The event was not confirmed because the product was not available for inspection.Method & results: product evaluation and results: review of the case session files was not performed as case session data was not provided.Clinician review: no medical records were received for review with a clinical consultant.Product history review: a review of device history records could not be performed as the device was not properly identified.Complaint history review: a review of complaints in trackwise could not be performed as the device was not properly identified.Conclusions: the alleged failure mode was not confirmed because the product was not available for inspection.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.
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Search Alerts/Recalls
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