MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 4; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Catalog Number 180614 |
Device Problems
Loss of Osseointegration (2408); Osseointegration Problem (3003)
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Patient Problems
Pain (1994); Injury (2348); Inadequate Osseointegration (2646)
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Event Date 08/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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An evaluation of the device cannot be performed as the device was not returned to the manufacturer.Should additional information become available it will be reported in a supplemental report upon completion of the investigation.
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Event Description
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Mako uni pka performed (b)(6) 2018.Revised to tka for tibial loosening (b)(6) 2018.Revised to triathlon tka.Pain and x-ray changes noted at follow up appointment, revision case booked.
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Manufacturer Narrative
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An event regarding loosening involving a mako baseplate was reported.The event was confirmed through clinician review of the medical records provided.No product was returned for evaluation, one photograph of the baseplate was provided.The photograph shows the baseplate with the fixation side/underside facing up.There is bone cement, bone ingrowth and blood visible on the baseplate.The explant photograph of the tibial device at revision shows the cemented underside of the baseplate with round-off of the trabecular cement impressions to confirm this device was loose at time of revision.Bone cement remnants in and around the joint space after cementation of a mako partial knee device contributed to third-body wear effects with early osteolysis and consequent tibial loosening requiring revision.Because cementation is part of surgical technique under responsibility of the surgeon, principal failure mode is procedure-related.Indicated all devices were manufactured and accepted into final stock with no relevant reported discrepancies.There have been no other similar events for the lot referenced.An event regarding revision due to loosening was reported.The medical review indicated that: the explant photograph of the tibial device at revision shows the cemented underside of the baseplate with round-off of the trabecular cement impressions to confirm this device was loose at time of revision.Bone cement remnants in and around the joint space after cementation of a mako partial knee device contributed to third-body wear effects with early osteolysis and consequent tibial loosening requiring revision.Because cementation is part of surgical technique under responsibility of the surgeon, principal failure mode is procedure-related.No further investigation is required at this time.If additional information becomes available to indicate further evaluation is warranted, this record will be reopened.
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Event Description
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Mako uni pka performed (b)(6) 2018.Revised to tka for tibial loosening (b)(6) 2018.Revised to triathlon tka.Pain and x-ray changes noted at follow up appointment, revision case booked.
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Search Alerts/Recalls
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