MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-LM/RL-SZ 5; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLY
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Catalog Number 180605 |
Device Problem
Failure to Osseointegrate (1863)
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Patient Problems
Injury (2348); Inadequate Osseointegration (2646)
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Event Date 02/04/2020 |
Event Type
Injury
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Manufacturer Narrative
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An event regarding loosening involving a mako tibial component was reported.The event was not confirmed.Method & results: product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following:the photo displayed a uni femoral component and tibial component with blood and cement on it.Nothing else remarkable to report.Medical records received and evaluation: no medical records were received for review with a clinical consultant.Product history review: not performed as the device lot details were not provided.Complaint history review: not performed as the device lot details were not provided.Conclusions: it was reported that patient's right partial knee was revised due to loosening and cement appeared not to have bonded with native bone.The event could not be confirmed and the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Revision of restoris medial unicomp due to loosening.Cement appeared not to have bonded with native bone.Revised to a triathlon total knee.
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Event Description
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Revision of restoris medial unicomp due to loosening.Cement appeared not to have bonded with native bone.Revised to a triathlon total knee.
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Manufacturer Narrative
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Reported event an event regarding loosening involving a mako tibial component was reported.The event was not confirmed.Method & results -product evaluation and results: the reported device was not returned however photographs were provided for review.The photographs note the following: the photo displayed a uni femoral component and tibial component with blood and cement on it.Nothing else remarkable to report.-medical records received and evaluation: no medical records were received for review with a clinical consultant.-product history review: not performed as the device lot details were not provided.-complaint history review: not performed as the device lot details were not provided.Conclusions: it was reported that patient's right partial knee was revised due to loosening and cement appeared not to have bonded with native bone.The event could not be confirmed and the exact cause of the event could not be determined because insufficient information was provided.Further information such as pathology reports, pre- and post-operative x-rays and the primary operative report as well as patient history and follow-up notes are needed to complete the investigation for determining the root cause.No further investigation for this event is possible at this time.If devices and / or additional information become available to indicate further evaluation is warranted, this record will be reopened.Product surveillance will continue to monitor for trends.Corrective action/preventive action: no action is required at this time as there is no indication to suggest a product nonconformity or unanticipated hazard.
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Search Alerts/Recalls
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