Model Number 111645 |
Device Problems
Fracture (1260); Insufficient Information (3190)
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Patient Problem
Tissue Damage (2104)
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Event Date 11/05/2019 |
Event Type
Injury
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Manufacturer Narrative
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As part of the 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 after right mako knee implantation on (b)(6) 2019, post-op x-rays revealed the femoral checkpoint was in the patient.On (b)(6) 2019, patient underwent surgery to remove the checkpoint.The rep who reported the (b)(6) surgery was not present for either procedure, but two mps's were present for the (b)(6) procedure.Rep reported 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 after right mako knee implantation on (b)(6) 2019, post-op x-rays revealed the femoral checkpoint was in the patient.On (b)(6) 2019, patient underwent surgery to remove the checkpoint.The rep who reported the november surgery was not present for either procedure, but two mps's were present for the october procedure.Rep 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: it was reported that after right mako knee implantation on (b)(6) 2019, post-op x-rays revealed the femoral checkpoint was in the patient.On (b)(6) 2019, patient underwent surgery to remove the checkpoint.The rep who reported the november surgery was not present for either procedure, but two mps's were present for the october procedure.Rep reported that no further information will be released by the hospital or surgeon.Product evaluation and results: product inspection was not performed as product was not available for inspection.Product history review: product history review was not conducted as lot number was not provided complaint history review: complaint history review was not conducted as lot number was not provided conclusions: the alleged failure is due to the user error,since user has not followed the surgical protocol.There is no issue with the device.If device and/or additional information become available, this investigation will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no nc and capa associated with the product and failure mode reported in this event.
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Search Alerts/Recalls
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