An event regarding loosening involving a mako femoral component was reported.The event was confirmed.Method and results: device evaluation and results: a visual, functional and dimensional inspection could not be performed as the device was not returned.Medical records received and evaluation: the provided medical information was submitted to a consulting clinician who indicated: "no patient demographics, no clinical or past medical history, no follow-up between november of 2012 and april of 2017, no serial x-rays, no revision operative report, and no examination of the explanted components are available.Reported outcomes of unicompartmental knee arthroplasty are not as good as total knee arthroplasty with the most common indication for conversion to total knee arthroplasty noted as progression of osteoarthritis to the other compartments and implant loosening.These are the likely causes of the bilateral conversions to total knee arthroplasties and are not shown to be related to factors of faulty unicompartmental knee arthroplasty component¿s design, manufacturing or materials." 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: the reported event was confirmed as per provided medical records reviewed by consulting clinician who indicated that most common indication for conversion to total knee arthroplasty noted as implant loosening.The progression of osteoarthritis noted as the likely cause of the event and is not shown to be related to factors of faulty unicompartmental knee arthroplasty component¿s design, manufacturing or materials.Further information such as patient demographics, clinical or past medical history, follow-up, serial x-rays, and revision operative report are needed to determine the root cause.If the devices and/or additional information are received, this investigation will be reopened and re-evaluated.
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The doctor revised a bilateral mako medial uni patient to a total knee with a 5mm augment on each tibia.Original surgery was done (b)(6) 2012.This pi is for the left knee.Event update: revision was due to pain.Nothing else was made available by the hospital.Update per medical review: x-ray printouts available for review include a series dated (b)(6) 2016, which is an ap of both knees, a patellar view of both knees, a lateral of the left knee, and a lateral of the right knee, demonstrating bilateral medial unicompartmental knee arthroplasties with bilaterally loose, subsided tibial components and radiolucencies behind both femoral components.
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