An event regarding altr involving a mako stem was reported.The event was confirmed through medical review.Method & results: -product evaluation and results: material analysis, visual, functional and dimensional inspections could not be performed as the device remains implanted.-clinician review: a patient underwent bilateral staged tha for oa.The procedures used restoris components, but use of the robot was not described in the op notes.Pins were noted in the or leger.The patient ultimately underwent staged bilateral revisions for altr.The right side was symptomatic, the left side was not (but had radiographic findings).No pre or postoperative records were provided for review, no laboratory values or radiographs were provided for review.-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.Conclusion: a patient underwent bilateral staged tha for oa.The procedures used restoris components, but use of the robot was not described in the op notes.Pins were noted in the or leger.The patient ultimately underwent staged bilateral revisions for altr.The right side was symptomatic, the left side was not (but had radiographic findings).No pre or postoperative records were provided for review, no laboratory values or radiographs were provided for review.Event confirmation: primary tha and revision arthroplasty can be confirmed.The description of the intraoperative findings would point to altr with pseudotumor, but pathology confirmation was not provided.Trunnionosis was only described for the right side.Concomitant infection cannot be confirmed.Root cause: the root cause for the revision surgery was pain on the right and signs of altr with fluid collection and pseudo tumor on the right and left.Additional information, including pathology reports, progress notes, x-rays, follow up notes and return of the device are needed to fully investigate the event.If further information becomes available or the product is returned, this investigation will be re-opened.
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