Model Number 209999 |
Device Problem
Insufficient Information (3190)
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Patient Problems
Pain (1994); Injury (2348)
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Event Date 06/03/2020 |
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 right mako partial knee was revised due to medial subsidence of the femoral component, subsidence of the tibial component, and extreme poly wear.Surgeon stated the opinion that poly wear/ debris was a cause or contributor for femoral subsidence.Patient was revised to a total knee.Rep provided the original usage report and explant pictures.The devices are allegedly available for return, otherwise the rep confirmed that no further information will be released.
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Manufacturer Narrative
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Reported event: ¿it was reported that the patient's right mako partial knee was revised due to medial subsidence of the femoral component, subsidence of the tibial component, and extreme poly wear.Surgeon stated the opinion that poly wear/ debris was a cause or contributor for femoral subsidence.Patient was revised to a total knee.Rep provided the original usage report and explant pictures.The devices are allegedly available for return, otherwise the rep confirmed that no further information will be released by the hospital or surgeon.¿ product evaluation and results: review of the case session files was not performed as case session data was not provided.Product history review: review of the device history records was not completed as the robot number/product information was not provided.Complaint history review: a search of the complaint database under device identification pn 209999 reports no similar complaints for pka software - other.Conclusions: the exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the case session/log data are needed to complete the investigation for determining root cause.No additional investigation or specific actions are required.If additional information is received then the complaint will be reopened.Corrective action/preventive action: a review of stryker¿s nc/capa database indicated there have been no ncs or capas associated with the product and failure mode reported in this event.H3 other text : device not returned.
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Event Description
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It was reported that the patient's right mako partial knee was revised due to medial subsidence of the femoral component, subsidence of the tibial component, and extreme poly wear.Surgeon stated the opinion that poly wear/ debris was a cause or contributor for femoral subsidence.Patient was revised to a total knee.Rep provided the original usage report and explant pictures.The devices are allegedly available for return, otherwise the rep confirmed that no further information will be released.
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Search Alerts/Recalls
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