No product was returned or pictures provided; visual and dimensional evaluations could not be performed.The dhr was reviewed and no discrepancies relevant to the reported event were found.Medical records and radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: right patellar fracture post total knee arthroplasty, loosened patellar implant.Procedure: revision right patellar button with partial patellectomy.Patient reported an onset of pain in his knee during a period of time where was being very physically active, x-ray demonstrated a vertical longitudinal fracture of the patella (bone) at the junction of the middle and lateral 3rd.He has an extremely large patella, and the patellar button only covered a portion of it, even though it was the largest size available.Dense scar tissue excised.The (bone) fracture was over a portion of the button, which had some deformity to it(implant), and therefore needed to be revised.Fractured lateral bone fragment excised, loose patellar implant removed, new patellar implant applied to the intact patellar bone fragment.Images not being sent to mmi at this time.A definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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