MAKO SURGICAL CORP. MCK TIBIAL BASEPLATE-RM/LL-SZ 3; PROSTHESIS, KNEE PATELLOFEMOROTIBIAL, PARTIAL, SEMI-CONSTRAINED, CEMENTED, POLYM
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Model Number 180613 |
Device Problem
Loss of Osseointegration (2408)
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Patient Problem
Inadequate Osseointegration (2646)
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Event Date 10/29/2020 |
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.Device not returned.
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Event Description
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A restoris baseplate was revised due to loosening.Right medial unicomp.
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Manufacturer Narrative
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Reported event: an event regarding loosening involving a mako baseplate was reported.The event was not confirmed.Method & results: product evaluation and results: the device was not returned.Visual inspection of the received image of the device noted the explant covered with biological material in the posterior part.Dimensional, functional inspection, and material analysis were not performed as the item was not returned.Clinician review: no medical records were received for review with a clinical consultant.Device history review: device history review indicated the devices accepted into final stock from the reported lot were free from discrepancies.Complaint history review: there has been no other event for the lot referenced.Conclusions: it was reported that the patient was revised due loose baseplate.The event could not be confirmed, nor the root cause determined because the devices were not returned for evaluation and insufficient medical information was provided.Further information such as medical documentation and returned devices are needed.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.Device not returned.
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Event Description
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A restoris baseplate was revised due to loosening.Right medial unicomp.
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Search Alerts/Recalls
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