Reported event: an event regarding loosening involving a mako baseplate was reported.The event was confirmed by clinician review of the provided medical records.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device was not returned.-clinician review: a review of the provided medical information by a clinical consultant indicated: "this document consists of a single ap view of a right knee if conventional orientation is used.No markings are present.It shows a medial partial knee replacement.It appears that there may have been subsidence of the tibial component.There is a radiolucent line extending from the medial portion of the tray under the base plate.[.] i cannot confirm the root cause of this event with certainty.The causes of early tibial loosening of a partial knee replacement are multifactorial including surgical technique factors including cementing technique and patient factors such as activity level and bmi.With the information provided i cannot assign any causality to the implant itself.".-product history review: review of the device history records indicate devices were manufactured and accepted into final stock with no relevant reported discrepancies.-complaint history review: there have been no other similar events for the lot referenced.Conclusions: it was reported that the patient was revised due to loosening of the tibial baseplate.The event was confirmed via clinician review of the provided x-ray images.The exact cause of the event could not be determined because insufficient information was provided.Further information such as return of the device, pathology reports, additional pre- and post-operative x-rays and the revision 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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